Request for Information on the DRAFT Scientific Integrity Policy of the National Institutes of Health, 65696-65707 [2023-20733]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65696-65707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

AGENCY: National Institutes of Health, HHS.

ACTION: Request for information.

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SUMMARY: The National Institutes of Health (NIH) is soliciting comments 
and suggestions from the public on the DRAFT ``Scientific Integrity 
Policy of the National Institutes of Health'' (DRAFT NIH Scientific 
Integrity Policy). The DRAFT NIH Scientific Integrity Policy codifies 
NIH's long-standing expectations to preserve scientific integrity 
throughout all NIH activities, establishes key roles and 
responsibilities for those who will lead the agency's scientific 
integrity program, and, as appropriate, establishes relevant reporting 
and evaluation mechanisms.

DATES: The DRAFT ``Scientific Integrity Policy of the National 
Institutes of Health'' is open for public comment for a period of 45 
days. To ensure consideration, comments must be submitted in writing by 
November 9, 2023.

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

[[Page 65697]]

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

FOR FURTHER INFORMATION CONTACT: Tyrone Spady, Ph.D., Director of the 
Science Policy Coordination, Collaboration & Reporting Division, Office 
of Science Policy, at (301) 496-9838 or [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Scientific integrity aims to make sure that science is conducted, 
managed, communicated, and used in ways that preserve its accuracy and 
objectivity and protect it from suppression, manipulation, and 
inappropriate influence (https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf). In 
its mission to seek fundamental knowledge about the nature and behavior 
of living systems and apply that knowledge to enhance health, lengthen 
life, and reduce illness and disability, NIH has always sought to 
incorporate robust scientific integrity principles and practices 
throughout every level of its scientific enterprise. In fostering 
scientific integrity, NIH aims to ensure that (1) scientific findings 
are objective, credible, and readily available to the public, and (2) 
the development and implementation of policies and programs is 
transparent, accountable, and evidence-based. NIH has numerous policies 
and procedures to ensure the Nation's investment in biomedical research 
is scientifically robust and rigorous and that our workforce maintains 
the highest standards of integrity. In supporting the NIH mission, all 
NIH researchers and staff are expected to:
     Foster an organizational culture of scientific integrity,
     Protect the integrity of the research process,
     Communicate science with integrity, and
     Safeguard scientific integrity.
    In 2012, NIH summarized the key components of its commitment to 
fostering scientific integrity in its NIH Policies and Procedures for 
Promoting Scientific Integrity Report (www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf), which outlines NIH's role in fostering 
scientific integrity as a funder of research, a research institution, 
and a policy development agency. In 2021, the White House released its 
Presidential Memorandum on Restoring Trust in Government Through 
Scientific Integrity and Evidence-Based Policymaking 
(www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/). The Memorandum tasks NIH 
and other agencies to update their scientific integrity policies as 
appropriate to ensure agency alignment with the principles set forth 
therein and in Protecting the Integrity of Government Science 
(www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf), a report of the 
Scientific Integrity Fast-Track Action Committee of the National 
Science and Technology Council (NSTC), and A Framework for Federal 
Scientific Integrity Policy and Practice (https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf), a guidance document released by the 
Scientific Integrity Framework Interagency Working Group of the NSTC. 
In response to the Memorandum, and in accordance with its continued 
commitment to promoting scientific integrity, NIH has developed the 
DRAFT Scientific Integrity Policy, which is in alignment with the 
guidance set forth in the Presidential Memorandum and the draft 
Scientific Integrity Policy of the U.S. Department of Health and Human 
Services (www.hhs.gov/sites/default/files/draft-hhs-scientific-integrity-policy.pdf). The DRAFT NIH Scientific Integrity Policy 
articulates the procedures and processes in place at NIH that help 
maintain rigorous scientific integrity practices and proposes several 
new functions to further enhance scientific integrity at NIH and 
throughout the NIH biomedical research enterprise.
    NIH accomplishes its mission by funding extramural researchers 
throughout the country, conducting research within its intramural 
research program, and developing policies and programs to responsibly 
advance biomedical research. In 2022, NIH updated its NIH Policies and 
Procedures for Promoting Scientific Integrity (2022) report at https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf, 
which describes the robust processes in place to support scientific 
integrity for NIH-supported extramural research, intramural research, 
and policies and programs. Building upon this existing infrastructure 
for scientific integrity, the DRAFT NIH Scientific Integrity Policy 
proposes several new functions to further enhance existing practices 
and processes. For example, the DRAFT NIH Scientific Integrity Policy 
includes a Federal definition of scientific integrity that is shared 
across the U.S. Government. This alignment across the U.S. Government 
will ensure consistency in guidance and language, lending clarity and 
uniformity to interagency efforts concerning scientific integrity. The 
DRAFT NIH Scientific Integrity Policy also establishes the appointments 
of, and roles and responsibilities for, the positions of NIH Chief 
Scientist (CS) and Scientific Integrity Official (SIO). The CS and SIO 
will have prominent and critical responsibilities in steering NIH's 
scientific integrity efforts, advising NIH leadership on scientific 
issues, and playing key roles in NIH's adjudication efforts related to 
scientific integrity. The DRAFT NIH Scientific Integrity policy also 
includes NIH practices that will address important emerging topics in 
biomedical research, such as protecting against political interference.
    NIH looks forward to working across the U.S. Government to support 
our shared commitment to responsible stewardship of the Nation's 
investment in biomedical research by maintaining and bolstering 
rigorous scientific integrity practices in taxpayer-funded biomedical 
research.

Request for Information

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

[[Page 65698]]

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

Draft Scientific Integrity Policy of the National Institutes of Health

Purpose

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

Scientific Integrity at NIH

    The mission of NIH is to seek fundamental knowledge about the 
nature and behavior of living systems and apply that knowledge to 
enhance health, lengthen life, and reduce illness and disability. NIH 
accomplishes this mission by funding extramural researchers throughout 
the country, conducting research within its intramural research 
program, and developing policies and programs to responsibly advance 
biomedical research. Embedding principles of scientific integrity 
throughout the NIH enterprise relies on two key elements. The first 
element is an all-hands-on-deck approach in which scientific rigor and 
research quality are prioritized. The second element is having 
inclusive, robust processes that safeguard scientific integrity.
    In fostering scientific integrity, NIH aims to ensure that (1) 
scientific findings are objective, credible, and readily available to 
the public, and (2) the development and implementation of policies and 
programs is transparent, accountable, and evidence-based. NIH has 
numerous policies and procedures to ensure the Nation's investment in 
biomedical research is scientifically robust and rigorous and that our 
workforce maintains the highest standards of integrity.
    Public input and accountability are woven throughout NIH processes 
to assure the public of the credibility of our science and our 
scientific findings. These activities range from presenting potential 
scientific solicitations at public meetings (e.g., concept clearance) 
to soliciting community feedback during policymaking activities. In 
supporting the NIH mission, all NIH researchers and staff are expected 
to:
     Foster an organizational culture of scientific integrity,
     Protect the integrity of the research process,
     Communicate science with integrity, and
     Safeguard scientific integrity.
    NIH's long-standing commitment to fostering scientific integrity 
was summarized in its 2012 report NIH Policies and Procedures for 
Promoting Scientific Integrity at https://www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf. This document was updated in 
2022 at https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf, partly in response to the 2021 
Presidential Memorandum on Restoring Trust in Government Through 
Scientific Integrity and Evidence-Based Policymaking at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/ to reflect more than a 
decade of updates to agency policies and procedures that support 
scientific integrity. The NIH Scientific Integrity Policy articulates 
expectations to preserve scientific integrity throughout all NIH 
activities, establishes key roles and responsibilities for those who 
will lead the agency's scientific integrity program, and, as 
appropriate, establishes relevant reporting and evaluation mechanisms 
with a goal of ensuring scientific integrity is foundational to all NIH 
activities. The NIH Scientific Integrity Policy is consistent with the 
U.S. Department of Health and Human Services (HHS) Scientific Integrity 
Policy. The majority of procedures regarding scientific integrity 
described herein are longstanding and foundational to NIH-supported 
research. This Scientific Integrity Policy integrates existing and new 
practices under a single harmonized framework.

Effective Date and Policy Amendments

    This policy goes into effect 12 months after publication of the 
final policy in the Federal Register. This policy will be evaluated by 
NIH one year after its effective date and regularly thereafter. 
Proposals to amend this policy will be overseen by the NIH Scientific 
Integrity Officer (SIO), in collaboration with the NIH Scientific 
Integrity Council (Council) described below, and any such amendments 
will be communicated to HHS and the Director of the White House Office 
of Science and Technology Policy (OSTP) no later than 30 days after 
adoption.

Applicability and Scope

    All NIH employees; Public Health Service Commissioned Corps 
members; political appointees; clinical, research, and postdoctoral 
fellows; doctoral trainees; interns; and advisory committee members in 
their capacity as special Government employees, and those managing 
scientific activities and using scientific information in policymaking, 
are expected to adhere to NIH's policies when in the course of their 
official duties they propose, conduct, review, or communicate about 
science and scientific activities on behalf of NIH. When relevant, NIH 
has also implemented separate policies for contractors, collaborators, 
awardees, and volunteers to uphold the principles of scientific 
integrity established by this policy.

Exceptions

    This policy will be implemented consistent with applicable Federal 
law.

Definitions

    Allegation refers to a disclosure of a suspected loss of scientific 
integrity.
    Chief Scientist (CS) provides oversight of all NIH scientific 
integrity policies and procedures. NIH recognizes organizational 
culture starts with leadership at the highest levels. It has designated 
the NIH Principal Deputy Director as the NIH CS.
    Corrective scientific action refers to actions taken to restore the 
accuracy of the scientific record after a loss of scientific integrity 
has been determined, consistent with this policy, such as correction or 
retraction of published materials. In addition to scientific actions, 
administrative actions may also be taken in response to substantiated 
violations of this policy.
    Covered individuals include all NIH employees; Public Health 
Service Commissioned Corps members; political appointees; clinical, 
research, and postdoctoral fellows; doctoral trainees; interns; and 
advisory committee members in their capacity as special Government 
employees, when in the course of their official duties they propose, 
conduct, review, or communicate about science and scientific 
activities; and all levels of employees who manage or supervise 
scientific activities and use scientific information in policymaking. 
NIH contractors, partners, permittees, lessees, grantees, and 
volunteers who engage or assist in NIH scientific activities are not 
considered covered individuals but are expected to uphold

[[Page 65699]]

the principles of scientific integrity described in this policy, as 
incorporated into the terms of their engagement with NIH.
    Ethical behavior refers to activities that reflect norms for 
conduct that distinguish between acceptable and unacceptable behavior, 
such as honesty, lawfulness, equity, and professionalism, and to 
adherence to statutes, regulations, policies, and guidelines governing 
employee conduct.
    Federal agency refers to an Executive department, a U.S. Government 
corporation, and an independent establishment.
    Inclusivity refers to the practice of providing equal access to 
opportunities for full participation of all people and all groups, 
including marginalized, underserved, and underrepresented contributors, 
without bias or prejudice. Full participation is enabled through 
implementation of strategies that promote equitable access and fair 
treatment in the organization.
    Inappropriate influence refers to the attempt to shape or interfere 
in scientific activities or the communication about or use of 
scientific activities, against well-accepted scientific methods and 
theories and without scientific, legal, programmatic management, or 
security justification.1 2
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    \1\ Examples may include (1) suppressing a decisionmaker's 
ability to offer the best judgment based on scientific information; 
(2) suppressing, altering or delaying the release of a scientific 
product for any reason other than technical merit or providing 
advance notification; (3) removing or reassigning scientific 
personnel for any reason other than performance, conduct or 
budgetary constraints; (4) using scientific products that are not 
representative of the current state of scientific knowledge and 
research (for example because of a lack of appropriate peer review, 
poor methodology, or flawed analyses) to inform decision making and 
policy formulation; or (5) misrepresenting the underlying 
assumptions, uncertainties, or probabilities of scientific products. 
This is not intended to be an exhaustive list.
    \2\ Differences of scientific opinion are not necessarily 
inappropriate influence. Additionally, NIH officials are regularly 
expected to provide agency perspectives when acting in their 
official capacity.
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    Interference refers to inappropriate, scientifically unjustified 
intervention in the conduct, management, communication, or use of 
science. It includes censorship, suppression, or distortion of 
scientific or technological findings, data, information, or 
conclusions; inhibiting scientific independence during clearance and 
review; scientifically unjustified intervention in research and data 
collection; and inappropriate engagement or participation in peer 
review processes or on Federal advisory committees (FACs).
    Loss of scientific integrity refers to the failure to comply with 
this Scientific Integrity Policy or to adhere to objectivity, 
transparency, and ethical behavior when conducting, managing, using the 
results of, and communicating about science and scientific activities. 
This loss may include research misconduct or inappropriate influence in 
the conduct, communication, management, and use of science.\3\
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    \3\ A report by the Scientific Integrity Fast-Track Action 
Committee of the National Science and Technology Council. 
``Protecting the Integrity of Government Science.'' January 11, 
2022. Available at: https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf.
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    Policy refers to laws, regulations, procedures, administrative 
actions, incentives, or voluntary practices of Governments and other 
institutions.
    Policymaking refers to the (1) development of policies or making 
determinations about policy or management; (2) making determinations 
about expenditures of Federal agency funds; (3) implementing or 
managing activities that involve, or rely on, scientific activities.
    Political interference is inappropriately shaping or interfering in 
the conduct, management, communication, or use of science for 
inappropriate partisan advantage or such that it undermines 
impartiality, nonpartisanship, or professional judgement.
    Research integrity refers to the use of honest and verifiable 
methods in proposing, performing, and evaluating research; reporting 
research results with particular attention to adherence to rules, 
regulations, and guidelines; and following commonly accepted 
professional codes or norms.
    Research misconduct refers to fabrication, falsification, or 
plagiarism in proposing, performing, or reviewing research, or in 
reporting research results.\4\
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    \4\ Federal Research Misconduct Policy, 65 FR 76260, 76262 (Dec. 
6, 2000) and https://www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93/subpart-A/section-93.103.
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    Research security refers to safeguarding the research enterprise 
against the misappropriation of research and development to the 
detriment of national or economic security, related violations of 
research integrity, and foreign Government interference.
    Science refers to the full spectrum of scientific endeavors, 
including basic science, applied science, evaluation, engineering, 
technology, economics, social sciences, and statistics, as well as the 
scientific and technical information derived from these endeavors.
    Scientific activities refer to activities that involve the 
application of well-accepted scientific methods and theories in a 
systematic manner, and includes, but is not limited to, data 
collection, inventorying, monitoring, evaluation, statistical analysis, 
surveying, observations, experimentation, study, research, integration, 
economic analysis, forecasting, predictive analytics, modeling, 
technology development, and scientific assessment, as well as any 
findings derived from these activities.
    Scientific data refers to recorded factual material commonly 
accepted in the scientific community as of sufficient quality to 
validate and replicate research findings, regardless of whether the 
data are used to support scholarly publications. Scientific data does 
not include laboratory notebooks, preliminary analyses, completed case 
report forms, drafts of scientific papers, plans for future research, 
peer reviews, communications with colleagues, or physical objects, such 
as laboratory specimens.\5\
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    \5\ NIH Data Management and Sharing Policy at: https://sharing.nih.gov/data-management-and-sharing-policy.
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    Scientific integrity is the adherence to professional practices, 
ethical behavior, and the principles of honesty and objectivity when 
conducting, managing, using the results of, and communicating about 
science and scientific activities. Inclusivity, transparency, and 
protection from inappropriate influence are hallmarks of scientific 
integrity. (Note: this is the Official Federal Definition of Scientific 
Integrity, consistent with OSTP and HHS definitions.\6\)
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    \6\ A Framework for Federal Scientific Integrity Policy and 
Practice. Available at: https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf.
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    Scientific Integrity Council will assist the NIH SIO in iterative 
review, policy development, and priority setting to ensure that the 
existing policies and procedures are responsive to issues that arise in 
the scientific integrity space.
    Scientific Integrity Official (SIO) is the primary official for 
responsibilities over scientific integrity matters and reports to the 
NIH CS. This policy empowers the NIH SIO with the independence 
necessary to gather and protect information to support the review and 
assessment of scientific integrity concerns. The NIH SIO will also 
advocate for appropriate engagement of scientific leadership in 
policymaking. NIH recognizes organizational culture starts with 
leadership at the highest levels. NIH has designated the Associate

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Director of Science Policy as the NIH SIO.
    Scientific record refers to published information resulting from 
scientific activities. NIH is responsible for ensuring the accuracy of 
elements of the scientific record that are published by NIH.
    Scientist refers to an individual whose responsibilities include 
collection, generation, use, or evaluation of scientific and technical 
data, analyses, or products. NIH scientists are NIH employees and other 
covered individuals who conduct these activities. It does not refer to 
individuals with scientific and technical training whose primary job 
functions are in non-scientific roles (e.g., policymakers, 
communicators).

Roles and Responsibilities

Chief Scientist and Scientific Integrity Official

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

NIH Scientific Integrity Council

    The NIH SIO shall establish an NIH Council comprising career 
employees from across the NIH and from relevant NIH offices. This 
committee will assist the SIO in iterative review, policy development, 
and priority setting to ensure that the existing policies and 
procedures are responsive to issues that arise in the scientific 
integrity space.
    The primary responsibilities of the Council are to:
    1. Ensure that a well-informed and high-level group of experts 
supports scientific integrity at NIH;
    2. Ensure that the NIH Scientific Integrity Policy is implemented 
consistently across NIH;
    3. Review, assess, and revise the NIH Scientific Integrity Policy 
as needed;
    4. Engage NIH leadership in upholding the principles of scientific 
integrity, and maintaining leadership awareness of scientific integrity 
issues as necessary and appropriate;
    5. As requested, assist the SIO in adjudicating allegations of 
losses of NIH scientific integrity (particularly related to political 
interference) in cases where such allegations fall outside of existing 
processes managed by OER, OIR, OMA, and OIG; and
    6. Determine handling of investigation and adjudication proceedings 
from which the HHS SIO is recused.

Background on NIH Functions

Intramural Research

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

Extramural Research

    Approximately 80 percent of NIH's investment in biomedical and 
behavioral research supports extramural researchers at institutions in 
every state in the country. Given the size and breadth of this 
investment, NIH has a robust infrastructure to ensure scientific 
integrity is embedded throughout the extramural research continuum and 
its workforce. While the covered individuals for this policy consist 
primarily of NIH employees, the principles of scientific integrity are 
foundational to NIH's role in funding extramural biomedical research, 
and the importance of scientific integrity is integrated throughout all 
NIH does as a funder of biomedical research. As such, existing policies 
to maintain scientific integrity of extramural research will continue. 
More information about the NIH extramural research program can be found 
on the NIH OER website at https://grants.nih.gov/aboutoer/intro2oer.htm.

NIH as a Policy Development Agency

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

Policy Requirements

Promoting a Culture of Scientific Integrity

    NIH leadership at all levels recognizes, supports, and promotes 
this policy and its underlying principles, and models behavior 
consistent with a strong culture of scientific integrity.

[[Page 65701]]

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

I. Protecting Scientific Processes
II. Ensuring the Free Flow of Scientific Information
III. Supporting Policymaking Processes
IV. Ensuring Accountability
V. Protecting Scientists
VI. Professional Development for Government Scientists, and
VII. Federal Advisory Committees
I. Protecting Scientific Processes
    NIH has implemented a suite of efforts to protect the integrity of 
research processes from bias and interference, which is essential to 
upholding public trust and confidence. These efforts rely on 
transparent processes, diverse community engagement, management of real 
or apparent conflicts of interest, and robust and open dialogue. NIH 
utilizes a variety of mechanisms to achieve these aims, such as holding 
policy discussions in open settings, soliciting public input on future 
research directions, and the use of Federal advisory committees (FACs) 
to advise the agency. In addition, for covered individuals, NIH 
explicitly prohibits political interference or inappropriately shaping 
or interfering in the conduct, management, communication, or use of 
science for inappropriate partisan advantage or such that it undermines 
impartiality, nonpartisanship, or professional judgement. Further 
processes will be developed and documented to support this policy in an 
NIH manual chapter.
    It is the policy of NIH to:
    1. Prohibit political interference or other inappropriate influence 
in the design, proposal, conduct, management, evaluation, communication 
of, and use of scientific activities conducted by covered individuals.
    2. Prohibit inappropriate restrictions on resources and capacity 
that limit and reduce the availability of science and scientific 
products outside of normal budgetary or priority-setting processes or 
without scientific, legal, or security justification.\7\
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    \7\ This provision is further outlined in the NIH Policy Manual 
Chapter 3005 on Review and Evaluation of Intramural Programs. 
Available at: https://policymanual.nih.gov/3005.
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    3. Require that leadership and management ensure that covered 
individuals engaged in scientific activities can conduct their work 
objectively and free from political interference or other inappropriate 
influence.
    4. Require reasonable efforts by covered individuals to ensure the 
fidelity of the scientific record and to correct identified 
inaccuracies that pertain to their contribution to any scientific 
records.
    5. Require that covered individuals represent their contributions 
to scientific work fairly and accurately and neither accept nor assume 
unauthorized and/or unwarranted credit for another's accomplishments. 
To be named as an author, contributors should have made a substantial 
contribution or provided editorial revisions that include critical 
intellectual content, approved the final version, and agreed to be 
accountable for all aspects of the work to which they contributed. 
Prior consent should be obtained from each author to be represented on 
a particular work. Obtaining prior consent for acknowledgements is also 
a good practice.\8\
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    \8\ This provision is further outlined in the 2023 8th Edition 
of Guidelines and Policies for the Conduct of Research in the 
Intramural Research Program at NIH. Available at: https://oir.nih.gov/system/files/media/file/2023-08/guidelines-conduct_research.pdf.
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    6. Ensure independent review of scientific activities conducted by 
covered individuals as appropriate to ensure scientific integrity.\9\
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    \9\ This provision is further outlined in the NIH Policy Manual 
Chapter 3005 on Review and Evaluation of Intramural Programs. 
Available at: https://policymanual.nih.gov/3005.
---------------------------------------------------------------------------

    7. Require that covered individuals comply with NIH policies and 
procedures for planning and conducting scientific activities and show 
appropriate diligence toward protecting and conserving Federal research 
resources, such as equipment and other property, and records of data 
and results that are entrusted to them.
    8. Prohibit research misconduct, the deliberate or reckless use of 
improper or inappropriate research methods or processes, and 
noncompliance with practices that safeguard the quality of research and 
other scientific activities or enhance research security for covered 
individuals.\10\
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    \10\ This provision is further outlined in the NIH Policy Manual 
Chapter 3006 on NIH Intramural Research Program (IRP) Research 
Misconduct Proceedings. Available at: https://policymanual.nih.gov/3006.
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    9. Require that covered individuals design, conduct, manage, 
evaluate, and communicate about scientific research and other 
scientific activities honestly and thoroughly, and disclose any 
conflicts of interest to their supervisor or other appropriate NIH 
official(s) for their determination as to whether a recusal, 
disclaimer, or other action is appropriate, consistent with NIH ethics 
policies and procedures.\11\
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    \11\ This provision is further outlined in the NIH Conflict of 
Interest and Confidentiality Certification for Individuals 
Evaluating all NIH Intramural Programs. Available at: https://oir.nih.gov/system/files/media/file/2021-08/conflict_of_interest-bsc_reviews.pdf.
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    10. Require that research conducted by covered individuals 
involving the participation of human subjects and the use of non-human 
animals is conducted in accordance with applicable,

[[Page 65702]]

established laws, regulations, policies, and ethical 
considerations.\12\
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    \12\ This provision is further outlined in the NIH Policy Manual 
Chapter 3014 on NIH Intramural Human Research Protection Program and 
the NIH Policy Manual Chapter 3040-2 on Animal Care and Use in the 
Intramural Research Program. Available at: https://policymanual.nih.gov/3014 and https://policymanual.nih.gov/3040-2 
respectively.
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    11. Support and enhance scientific integrity with the understanding 
that violations of scientific integrity can have a disproportional 
impact on underrepresented groups or weaken the equitable delivery of 
Federal Government programs.
    12. Consistent with OSTP guidance and relevant HHS and NIH policy, 
prohibit personnel of NIH engaged in intramural research from 
participation in foreign talent recruitment programs, unless the 
participation is in an international conference or other international 
exchange, partnership, or program for which such participation has been 
approved by the appropriate authority in NIH.\13\
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    \13\ Health Extenders, Improving Access to Medicare, Medicaid, 
and CHIP, and Strengthening Public Health Act of 2022, Public Law 
117-328, Division FF, title II, section 2321 (Jan 3, 2023) and Chips 
and Science Act, Public Law 117-167, title VI, subtitle D, section 
10631 (Aug 9, 2022). OSTP guidance and relevant HHS and NIH policies 
to implement this legislation are forthcoming at the time of 
publication of this policy.
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    13. Consistent with OSTP guidance and relevant HHS and NIH policy, 
require disclosure of participation in foreign talent recruitment 
programs, including the provision of copies of all grants, contracts, 
or other agreements related to such programs, and other supporting 
documentation related to such programs, as a condition of receipt of 
Federal extramural research funding awarded through NIH.\14\
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    \14\ Health Extenders, Improving Access to Medicare, Medicaid, 
and CHIP, and Strengthening Public Health Act of 2022, Public Law 
117-328, Division FF, title II, section 2321 (Jan 3, 2023) and Chips 
and Science Act, Public Law 117-167, title VI, subtitle D, section 
10631 (Aug 9, 2022). OSTP guidance and relevant HHS policies to 
implement this legislation are forthcoming at the time of 
publication of this policy.
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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, 
rigorous, research results, and their publication in reputable, peer-
reviewed scientific journals. NIH's IRP researchers adhere to a NIH-
wide Policy for Manuscript and Abstract Clearance Procedures at https://oir.nih.gov/sourcebook/submitting-research-publications/publication-abstract-clearance and follow established guidance to ensure 
transparency in research findings through Processes for Authorship 
Dispute Resolution at https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process if the situation arises.
    It is the policy of NIH to:
    1. Facilitate the free flow of scientific and technological 
information, to the extent permissible by Federal laws and regulations. 
Consistent with open science expectations, NIH shall expand and promote 
access to scientific and technological information by making it 
available freely and without embargo to the public in an online digital 
format.15 16 17 18
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    \15\ White House Office of Science and Technology Policy 
Memorandum for the Heads of Executive Departments and Agencies on 
Increasing Access to the Results of Federally Funded Scientific 
Research. February 22, 2013. Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf.
    \16\ White House Office of Science and Technology Policy 
Memorandum for the Heads of Executive Departments and Agencies on 
Ensuring Free, Immediate, and Equitable Access to Federally Funded 
Research. August 25, 2022. Available at: https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf.
    \17\ This provision is further outlined in the NIH Policy Manual 
Chapter 1184 on Preparation and Clearance of Scientific, Technical, 
and Public Information Presented by NIH Employees or Produced for 
Distribution by NIH. Available at: https://policymanual.nih.gov/1184.
    \18\ This provision is further outlined in the NIH Data 
Management and Sharing Policy. Available at: https://sharing.nih.gov/data-management-and-sharing-policy.
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    2. Ensure that scientific findings and products created by NIH 
scientists are not unduly suppressed, delayed, or altered for political 
purposes and are not subjected to inappropriate influence.
    3. Encourage, but not require, NIH scientists to participate in 
their official capacities in communications with the media regarding 
their scientific activities and areas of expertise, subject to 
limitations of Government ethics rules. In communicating with the 
media, NIH scientists are encouraged to seek advice from career NIH 
communications experts.
    4. Allow, subject to limitations of Government ethics rules, NIH 
scientists to express their personal views and opinions with 
appropriate written or oral disclaimers, including on social media.\19\ 
NIH scientists may name NIH as their employer in the context of 
biographical information but shall refrain from making or publishing 
statements that could be construed as being judgments of, or 
recommendations on, NIH or any other Federal Government policy, 
including the use of NIH or other U.S. Government seals or logos, 
unless they have secured appropriate prior approval to do so.
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    \19\ This provision is further outlined in the United States 
Office of Government Ethics Standards of Conduct and 18 U.S.C. 208 
as Applied to Official Social Media Use. Available at: https://
oge.gov/web/oge.nsf/News+Releases/EAE37A7DA3C38BF38525894700775339/
$FILE/LA-23-
03%20The%20Standards%20of%20Conduct%20and%2018%20U.S.C.%20%C2%A7%2020
8%20as%20Applied%20to%20Official%20Social%20Media%20Use.pdf.
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    5. Ensure that the work and conclusions of NIH scientists and the 
work and conclusions of scientists funded or supported by the Federal 
Government are accurately represented in NIH communications. If 
communication documents significantly rely on a scientist's research, 
identify them as an author, or represent their scientific opinion, the 
scientist shall be given the option to review the scientific content of 
proposed communication documents.
    6. Ensure that NIH scientists may communicate their scientific 
activities objectively without political interference or other 
inappropriate influence. Scientific products (e.g., manuscripts for 
scientific journals, presentations for workshops, conferences, and 
symposia) shall adhere to relevant NIH technical review procedures.
    7. Require that NIH officials, including communications officers, 
shall not alter, nor direct NIH scientists and technology experts to 
alter, scientific and technological research findings or presentation 
of research findings in a manner that may compromise the objectivity or 
accurate representation of those findings.
    8. Require that technical review and clearance processes include 
provisions for timely clearance and expressly forbid censorship, 
unreasonable delay, and suppression of objective communication of data 
and results

[[Page 65703]]

without scientific, legal, or security justification.
    9. Ensure that scientific information is accurately represented in 
responses provided by NIH to Congressional inquiries, testimony, and 
other requests.
    10. Accurately represent the work and conclusions of NIH scientists 
in NIH social media communications and provide appropriate guidance to 
NIH scientists on the use of NIH social media.
    11. Violations of clearance policies that result in suppression, 
delay, or alteration of scientific and technological information 
produced by NIH scientists without scientific, legal, or security 
justification constitute violations of the NIH Scientific Integrity 
Policy and may be reported under the procedures for Addressing 
Scientific Integrity Concerns.
III. Supporting Policymaking Processes
    NIH utilizes multiple mechanisms for ensuring transparency and 
accountability in developing policy. The development of science policy 
at NIH generally follows procedures set forth under the Administrative 
Procedure Act (5 U.S.C. Subchapter II) at https://www.archives.gov/federal-register/laws/administrative-procedure, where applicable, and 
draft policy proposals are routinely issued through the NIH Guide and 
the Federal Register, as appropriate, to obtain early feedback into 
policy proposals. Once a proposal has been issued for public comment, 
it is often supplemented with informational webinars, interactive 
discussion sessions, and a robust public engagement plan to promote 
broad dissemination and engagement in the policymaking process. NIH 
considers all comments submitted on draft polices and policy proposals 
to ensure final policy proposals are informed by the community and 
capable of responding to emerging opportunities and challenges. Final 
policies are also issued through the NIH Guide and the Federal 
Register, as appropriate, and incorporated into the NIH Grants Policy 
Statement and NIH Policy Manual, as appropriate. Policies are also 
posted to NIH websites with additional resources such as Frequently 
Asked Questions and other supplemental resources as needed.
    It is the policy of NIH to:
    1. Ensure the quality, accuracy, and transparency of scientific 
information used to support policy and decision making, including by:
    a. Using scientific information that is subject to well-established 
scientific processes.
    b. Ensuring that scientific data and research used to support 
policy decisions undergo review by qualified experts, where feasible 
and appropriate, and consistent with law.
    c. Adhering to the Office of Management and Budget Final 
Information Quality Bulletin for Peer Review.\20\ For example, as 
described in the Bulletin, when independent peer reviews of scientific 
information products are conducted by contractors, a conflict-of-
interest review shall be conducted.
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    \20\ Office of Management and Budget. ``Final Information 
Quality Bulletin for Peer Review.'' Federal Register. Doc. 05-769. 
Available at: https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review.
---------------------------------------------------------------------------

    d. Reflecting scientific information appropriately and accurately 
and making scientific findings or conclusions considered or relied on 
in policy decisions publicly available online and in open formats, to 
the extent practicable.
    2. Where legally permissible and appropriate, directly consult with 
scientists whose work is being used in policy and management decisions 
to ensure that the science is accurately represented and interpreted.
    3. Ensure, to the extent possible, the accuracy of NIH 
communication of the science upon which a policy decision is based.
    4. Ensure that covered individuals are free to express differing 
scientific opinions free from political interference or inappropriate 
influence.
IV. Ensuring Accountability
    NIH is firmly committed to establishing and formalizing procedures 
to identify and adjudicate allegations regarding compromised scientific 
processes or technological information. NIH has established several 
adjudication processes with distinct offices (i.e., OER, OIR, and OMA), 
to address different ways in which scientific integrity may be 
violated. Each office handles allegations pertaining to its respective 
jurisdiction, but anyone may submit an oral or written allegation via 
email or hotline. When an allegation or complaint is received, the 
appropriate office determines if it is specific, credible, and meets 
the definition of misconduct or an integrity violation. The procedures 
each office takes for investigating allegations or complaints, 
adjudication, and appeals are further detailed in the 2022 update to 
the NIH Policies and Procedures for Promoting Scientific Integrity at 
https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf. The designation of an NIH SIO will allow for more 
centralized interagency communication and coordination concerning 
allegations to ensure effective oversight and promote scientific 
integrity within the Federal Government. Additionally, the NIH SIO will 
provide review and adjudication of allegations (particularly related to 
political interference) that do not fall under the purview of these 
existing offices.
    It is the policy of NIH to:
    1. Ensure correction of the scientific record and implementation of 
corrective scientific actions when allegations of a loss of scientific 
integrity are substantiated.
    2. Encourage and facilitate early informal or formal consultation 
between NIH employees and scientific integrity officials to advise on 
preventing loss of scientific integrity, to determine whether a loss of 
scientific integrity has potentially occurred, and to ascertain whether 
an allegation should be referred elsewhere for resolution.
    3. Provide clear guidance on how to formally and confidentially 
report concerns and allegations of loss of scientific integrity. Those 
who report concerns and allegations need not be directly involved or 
witness a violation.
    4. Ensure that the NIH SIO or other NIH entities draft procedures, 
as needed, to respond to allegations of loss of scientific integrity in 
a timely, objective, and thorough manner. These procedures shall 
include an initial assessment and review, a fact-finding process, an 
adjudication or determination including description of remedies and 
preventative measures to safeguard the science, and reporting.
    5. These procedures shall document the necessary aspects for each 
step of the process as well as the roles of NIH SIO and other agency 
staff in the process.
V. Protections
    NIH prioritizes safe and respectful work environments that are free 
from harassment, including sexual harassment, discrimination, or other 
forms of inappropriate conduct that can result in a hostile work 
environment. Additionally, it is unlawful for NIH to take or threaten 
to take a personnel action against an employee because he or she made a 
protected disclosure of wrongdoing. A protected disclosure is defined 
as a disclosure of information that the individual reasonably believes 
is evidence of a violation of law, rule, or regulation; gross 
mismanagement; gross waste of funds; and abuse of authority; or a 
substantial and specific

[[Page 65704]]

danger to public health or safety. Personnel actions that are covered 
by this can include poor performance review, demotion, suspension, 
termination, or revocation or downgrade of a security clearance. If 
staff members believe that whistleblower retaliation has occurred, they 
may get more information from the HHS OIG at https://oig.hhs.gov/about-oig/.
    It is the policy of NIH to:
    1. Select and retain candidates for NIH scientific and technical 
positions based on the candidate's scientific and technical knowledge, 
credentials, experience, and integrity, and hold them and their 
supervisors to the highest standards of professional and scientific 
ethics.\21\
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    \21\ This provision is further outlined in the NIH Sourcebook on 
Personnel. Available at: https://oir.nih.gov/sourcebook/personnel.
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    2. Promote diversity, equity, inclusion, and accessibility in the 
scientific workforce and to create and support the creation of safe 
workspaces that are free from harassment, discrimination, and 
exploitation.\22\
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    \22\ This provision is further outlined in the NIH Sourcebook 
Addendum to BSC Policies and Procedures. Available at: https://oir.nih.gov/sourcebook/processes-reviewing-nih-intramural-science/boards-scientific-counselors/addendum-policies-procedures.
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    3. Protect from reprisal those individuals who report allegations 
of loss of scientific integrity in good faith. Efforts will also be 
made to protect from inappropriate actions those covered individuals 
alleged to have compromised scientific integrity.
    4. Prevent NIH employees from intimidating or coercing NIH 
scientists to alter scientific data, findings, or professional opinions 
or from inappropriately influencing scientific advisory boards.
    5. Comply with whistleblower protections, specifically:
    a. The requirements of the Whistleblower Protection Act of 1989, 
and its expanded protections enacted by Public Law 103-424 and the 
Whistleblower Protection Enhancement Act of 2012, 5 U.S.C. part 
2302(b)(8)-(9).
    b. The National Defense Authorization Act's expansion of certain 
whistleblower protections to employees of Federal Government 
contractors, subcontractors, and grant recipients in 41 U.S.C. 4712.
    c. Presidential Policy Directive 19, which prohibits supervisors 
from taking, failing to take, or threatening to take or fail to take 
any action affecting an employee's eligibility for access to classified 
information in reprisal for making a protected disclosure.
    d. The Military Whistleblower Protection Act (codified at 10 U.S.C. 
1034), which is made applicable to the Public Health Service 
Commissioned Corps officers through section 1129 of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144), and 
implemented by Commissioned Corps Directive 121.06.
    6. Scientific integrity staff at NIH are protected by all 
applicable employee rights as required by law. Consistent with 
applicable law, an SIO or other scientific integrity staff may not be 
terminated or reassigned without good cause or legitimate 
organizational reason. Possible good cause reasons include, but are not 
limited to, consistent poor performance, inefficiency, neglect of duty, 
malfeasance, conviction of a felony, conduct involving moral turpitude, 
knowing violation of a law, rule, or regulation, gross mismanagement, 
gross waste of funds, and abuse of authority.
VI. Professional Development for Government Scientists
    A key aspect of the NIH effort to advance scientific integrity is 
encouraging NIH IRP researchers to engage with the broader research 
community in maintaining the highest ethical standards and scientific 
norms. Creating an inclusive environment for scientists from all 
backgrounds, including those from traditionally underrepresented 
groups, is essential to supporting scientific integrity. The IRP 
promotes professional development of all researchers from trainees at 
every level, to tenure-track and tenured investigators, and all other 
research staff. Scholarly writing, lecturing, editing, and publishing 
are essential parts of research and professional development. These 
activities are in the public interest and bring credit and distinction 
to both NIH and its employees. In encouraging researchers to share 
information about their official and professional activities, NIH seeks 
to advance scientific knowledge and contribute to its employees' 
professional education.
    It is the policy of NIH to:
    1. Encourage timely publication of research conducted by covered 
individuals such as in peer-reviewed, professional, scholarly journals, 
NIH technical reports and publications, or other appropriate 
outlets.\23\
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    \23\ This provision is further outlined in the NIH Data 
Management and Sharing Policy. Available at: https://sharing.nih.gov/data-management-and-sharing-policy.
---------------------------------------------------------------------------

    2. Encourage the sharing of scientific activities, findings, and 
materials developed by covered individuals through appropriate avenues 
including digital repositories.\24\
---------------------------------------------------------------------------

    \24\ This provision is further outlined in the NIH Data 
Management and Sharing Policy. Available at: https://sharing.nih.gov/data-management-and-sharing-policy.
---------------------------------------------------------------------------

    3. Encourage covered individuals to participate in and present 
research at professional meetings including workshops, conferences, and 
symposia.\25\
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    \25\ This provision is further outlined in the NIH Sourcebook on 
Tenure in the NIH Intramural Research Program. Available at: https://oir.nih.gov/sourcebook/tenure-nih-intramural-research-program.
---------------------------------------------------------------------------

    4. When appropriate, permit covered individuals to serve on 
editorial boards, as peer reviewers, or as editors of professional or 
scholarly journals.
    5. When appropriate, permit covered individuals to participate in 
professional societies, committees, task forces, and other specialized 
bodies of professional societies, including removing barriers to 
serving as officers or on governing boards of such societies, to the 
extent allowed by law.\26\
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    \26\ This provision is further outlined in the NIH Sourcebook on 
Activities with Outside Organizations and the NIH Official Duty 
Activities Chart. Available at: https://oir.nih.gov/sourcebook/ethical-conduct/research-ethics/nih-policies/intramural-extramural-collaborations/activities-outside-organizations and https://ethics.od.nih.gov/sites/default/files/topics/ODA/2-ODA-Chart.pdf, 
respectively.
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    6. Permit NIH scientists to receive honors and awards for 
contributions to scientific activities and discoveries to the extent 
allowed by law, and to accrue the professional recognition of such 
honors or awards.
    7. Permit NIH scientists to perform outreach and engagement 
activities, such as speaking to community and student groups, as part 
of their official duties as appropriate.

VII. Federal Advisory Committees

    FACs, as defined by the Federal Advisory Committee Act (FACA) at 
https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act, are an important tool within NIH for ensuring the 
credibility, quality, and transparency of NIH science. NIH shall adhere 
to FACA and develop policies in coordination with the General Services 
Administration and consistent with the guidance on lobbyists serving on 
FACs when convening FACs tasked with giving scientific advice.
    Consistent with all applicable laws and guidance regarding FACs, it 
is the policy of NIH to:
    1. Promote transparency in the recruitment of new FAC members,

[[Page 65705]]

including, when practical and appropriate, announcing vacancies with a 
notification in the Federal Register.
    2. Select members to serve on a scientific or technical FACs based 
on expertise, knowledge, and contribution to the relevant subject 
area.27 28 Additional factors that may be considered are 
availability of the member to serve, alignment with the relevant 
Federal Advisory Committee Membership Balance Plan, and the ability to 
work effectively on advisory committees.\29\ Ensure committee 
membership is fairly balanced in terms of points of view represented 
with respect to the functions to be performed by the 
FAC.30 31
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    \27\ This provision is further outlined in How Scientists Are 
Selected to Be Members of a Chartered Review Group. Available at: 
https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/CharteredReviewers.
    \28\ This provision refers to not only FACA Councils that have 
SGE members but also peer review FACA committees that have NIH peer 
review consultants as members.
    \29\ This provision is further outlined in the NIH Selection 
Criteria for NIH Advisory Committees. Available at: https://ofacp.nih.gov/sites/default/files/SelectionCriteria.pdf.
    \30\ 2010 Memorandum from the White House Office of Science and 
Technology Policy on Scientific Integrity. Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf.
    \31\ General Services Administration 41 CFR parts 101-6 and 02-3 
Federal Advisory Committee Management; Final Rule. Available at: 
https://www.gsa.gov/system/files/FACAFinalRule_R2E-cNZ_0Z5RDZ-i34K-pR.pdf.
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    3. Comply with current standards governing conflict of interest as 
defined in statutes and implementing regulations.32 33
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    \32\ This provision is further outlined in the NIH Policy Manual 
Chapter 1810 on Procedures for Avoiding Conflict of Interest for 
Special and other Federal Employees Serving as Advisory Committee 
Members. Available at: https://policymanual.nih.gov/1810-1.
    \33\ The NIH Office of Federal Advisory Committee Policy 
maintains the Special Government Employee (SGE) Portal for those 
interested in serving on an NIH Federal advisory committee as an 
SGE. The Portal contains all the requirements expected of advisory 
committee members who serve on advisory committees as SGEs, 
including ethics training, Foreign Activities and Lobbyist 
Certification, and the Confidential Financial Disclosure Report (OGE 
450) at: https://sgeportal.od.nih.gov/Pages/default.aspx.
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    4. Except when prohibited by law and to the extent practical, 
agencies should appoint members of scientific and technical FACs as 
Special Government Employees.
    5. Treat all reports, recommendations, and products produced by 
FACs solely as the reports, recommendations, and products of such 
committees rather than of the U.S. Government, and thus not subject to 
intra- or inter-agency revision. The role of the FACs is to provide 
advice or recommendations to the agency. The agency may then craft 
policy based on the FACs' advice or recommendations if it chooses to 
adopt those recommendations.

Addressing Scientific Integrity Concerns

    The NIH SIO has primary responsibility for assessing scientific 
integrity concerns and will develop procedures for addressing 
allegations of loss of scientific integrity and concerns that span or 
fall outside existing NIH adjudication mechanisms under the purview of 
OER, OIR, OMA, or OIG.\34\ In particular, the NIH SIO will manage 
scientific integrity concerns related to political interference, if 
they do not fall within existing processes. Procedures for handling 
scientific integrity concerns will be made available on the NIH 
website. For information about rights and remedies against retaliation, 
employees may contact the HHS OIG Whistleblower Protection 
Coordinator.\35\ As noted above, existing procedures under the purview 
of OER, OIR, OMA, and OIG should continue to be followed. When those 
existing mechanisms do not cover a scientific integrity concern:
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    \34\ OER reviews and refers allegations of research misconduct 
involving extramural researchers and peer review of grant 
applications to the HHS Office of Research Integrity (ORI) and may 
take corrective action against a grantee or peer reviewer based on 
the conduct identified in ORI findings. OIR reviews allegations 
related to research integrity involving NIH IRP researchers. The NIH 
Division of Program Integrity within OMA manages the review of 
allegations involving misuse of NIH grant or contractor funds, 
grantee or contractor conflicts of interest, and other misconduct or 
misuses of NIH resources by NIH employees or others doing business 
with NIH. The HHS OIG investigates allegations of criminal fraud, 
waste, and abuse. Further information about these processes and 
offices will be provided in a manual chapter.
    \35\ As appropriate, employees can also contact the NIH Office 
of Equity, Diversity, and Inclusion for information regarding 
retaliation based on protected equal employment opportunity, or the 
Office of Special Counsel for information regarding retaliation 
based on whistleblowing. Further information can be found at: 
https://www.edi.nih.gov/resolutions/resources/faqs and https://oig.hhs.gov/fraud/whistleblower/. Additionally, although encouraged 
to use the process detailed herein, employees may also disclose 
wrongdoing to their supervisor or another individual higher up in 
management, the HHS OIG, the Office of Special Counsel, or to 
Congress.
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    1. Concerns about a potential loss of scientific integrity at NIH 
may be reported to the NIH SIO by any individual who has knowledge of 
the situation.
    2. NIH employees are encouraged to seek an informal consultation 
with the NIH SIO or other relevant agency integrity officials to 
discuss whether a concern constitutes a potential loss of scientific 
integrity before submitting a formal complaint. Employees ultimately 
have the discretion to submit a formal complaint as they see fit.
    3. The SIO will oversee an initial assessment of each reported 
concern and determine whether to request additional information from 
the complainant or others and to determine whether a formal 
investigation is warranted. Additionally, if any reported concern falls 
within the purview of existing OER, OIR, OMA, or OIG processes, those 
mechanisms will instead be utilized.
    4. Should an investigation be opened, an investigation committee 
consisting of the NIH SIO and other agency integrity officials from the 
NIH Scientific Integrity Council will be convened to develop a factual 
record by exploring the allegation(s) in detail and consulting with 
subject matter experts, interviewing witnesses, and reviewing 
documentation as needed.
    5. Once the investigation is complete, the NIH SIO will determine 
whether scientific integrity was lost and report findings to the 
appropriate management entity.
    6. The complainant and respondent will be given the opportunity to 
appeal a finding or any corrective scientific actions taken.

Handling Differing Scientific Opinions

    Science and decisions based on science are strengthened by vigorous 
discussion and debate and by considering all available evidence. The 
process of challenging and improving ideas helps to guard against 
inadequate science and flawed analysis. NIH encourages its scientists 
to respectfully express and engage with differing views as an integral 
part of the scientific process.\36\ In some cases, such as when a 
scientific dispute has a significant impact on public health or policy, 
a formal scientific dispute resolution process may be necessary. The 
goal of scientific dispute resolution should be to ensure that all 
perspectives are heard and documented in an unbiased way. A 
satisfactory resolution may involve adopting one opinion over another, 
deciding to conduct additional studies, formulating an alternate theory 
reconciling the differing opinions, or documenting the disagreement for 
the benefit of policymakers and fellow scientists. These steps may be 
completed in any order and are not necessarily an exhaustive list of 
dispute

[[Page 65706]]

resolution measures among NIH scientists. In general:
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    \36\ Further information on the NIH IRP Authorship Conflict 
Resolution Process can be found in the NIH Sourcebook. Available at: 
https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process.
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     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.
     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.
     If the matter cannot be satisfactorily resolved by other 
means, a team may request assistance from OIR. The NIH SIO may be 
consulted if their assistance is requested or if there is a conflict of 
interest or perceived conflict of interest with relevant OIR staff.

Monitoring, Evaluating, and Reporting Scientific Integrity Activities 
and Outcomes

    NIH, working through HHS, will develop and implement an evaluation 
plan to regularly measure, monitor, and evaluate ongoing scientific 
integrity activities and outcomes. The plan will include a roadmap of 
activities, evaluation metrics, and methods of measurement for the 
purpose of ongoing improvement of scientific integrity processes, 
procedures, and policies. As part of the monitoring and evaluation 
plan, an annual report on the number and outcomes of investigations 
involving allegations of loss of scientific integrity will be 
published. To the extent possible, all descriptions of investigations 
will be anonymized.

Related Policies and Statutes

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

Research Misconduct

 Federal Research Misconduct Policy: https://www.federalregister.gov/documents/2000/12/06/00-30852/executive-office-of-the-president-federal-policy-on-research-misconduct-preamble-for-research
 Public Health Service Policies on Research Misconduct: https:/
/www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93
 NIH Policy Manual Chapter 3006--NIH Intramural Research 
Program (IRP) Research Misconduct Proceedings: https://policymanual.nih.gov/3006
 NIH IRP Policies and Procedures for Research Misconduct 
Proceedings: https://oir.nih.gov/system/files/media/file/2021-08/policy-nih_irp_research_misconduct_proceedings.pdf

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

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

Public Access

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

Human and Animal Subject Protections

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

Research Security

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

Whistleblower Protections

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

[[Page 65707]]

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

Other Related Policies

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

Authorities

    Pursuant to the 2021 Presidential Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based Policymaking 
at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/, and consistent with the 
2009 Presidential Memorandum on Scientific Integrity at https://obamawhitehouse.archives.gov/the-press-office/memorandum-heads-executive-departments-and-agencies-3-9-09 and the 2010 Memorandum from 
the White House Office of Science and Technology Policy on Scientific 
Integrity at https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf, all Federal 
agencies must establish a scientific integrity policy. The requirements 
of this policy are derived from the 2022 National Science and 
Technology Council (NSTC) Report of the Scientific Integrity Fast Track 
Action Committee, Protecting the Integrity of Government Science at 
https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf, and align with the 
principles set forth in the NSTC guidance document A Framework for 
Federal Scientific Integrity Policy and Practice at https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf.

    This policy is established in accordance with:

1. Public Law 111-358--The America COMPETES Reauthorization Act of 
2010, section 103, as amended
2. Public Law 115-435--The Foundations for Evidence-based Policymaking 
Act of 2018
3. Public Law 106-554--The Information Quality Act of 2000
4. 67 FR 8451--OMB Guidelines for Ensuring and Maximizing the Quality, 
Objectivity, Utility, and Integrity of Information Disseminated by 
Federal Agencies
5. 70 FR 2664--OMB Final Information Quality Bulletin for Peer Review
6. 65 FR 76260-76264--Federal Policy on Research Misconduct
7. Public Law 101-12--The Whistleblower Protection Act (WPA) of 1989, 
as amended
8. 41 U.S.C. 4712--The National Defense Authorization Act, Enhancement 
of contractor protection from reprisal for disclosure of certain 
information
9. 5 U.S.C. 13103 et seq.--The Ethics in Government Act of 1978, as 
amended, and 5 CFR parts 2634 and 2635, Executive Branch Financial 
Disclosure, Qualified Trusts, and Certificates of Divestiture and 
Standards of Ethical Conduct for Employees of the Executive Branch.
10. 18 U.S.C. 201-209--Statutes regarding Bribery, Graft and Conflicts 
of Interest
11. 5 CFR parts 5501 and 5502--Supplemental Standards of Ethical 
Conduct for Employees of the Department of Health and Human Services
12. 5 U.S.C. Ch. 10--The Federal Advisory Committee Act of 1972
13. 45 CFR part 73, Standards of Conduct
14. 5 CFR part 735, Employee Responsibilities and Conduct
15. HHS Protection of Human Subjects Regulation (45 CFR part 46).
16. PPD 19--Protecting Whistleblowers with Access to Classified 
Information, 2012
17. M-20-12--OMB Phase 4 Implementation of the Foundations for 
Evidence-Based Policymaking Act of 2018: Program Evaluation Standards 
and Practices
18. 42 CFR part 93--Public Health Service Policies on Research 
Misconduct
19. 10 U.S.C. 1034, made applicable to the Public Health Service 
Commissioned Corps through section 1129 of the Food and Drug 
Administration Safety and Innovation Act, Public Law 112-144, and 
implemented by Commissioned Corps Directive (CCD) 121.06
20. Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, 
and Strengthening Public Health Act of 2022, Public Law 117-328, 
Division FF, title II, section 2321 (Jan 3, 2023)
21. Chips and Science Act, Public Law 117-167, title VI, subtitle D, 
section 10631 (Aug 9, 2022)

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