```

[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Rules and Regulations]
[Pages 92830-92840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25810]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 93

45 CFR Parts 46 and 73

Final Scientific Integrity Policy

AGENCY: Office of the Assistant Secretary for Planning and Evaluation, 
Office of the Secretary, HHS.

ACTION: Policy statement.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services (HHS) is 
publishing its Scientific Integrity Policy to increase access to and 
raise awareness of the Policy.

DATES: The effective date of the Policy is October 16, 2024.

FOR FURTHER INFORMATION CONTACT: Karen Wehner, Ph.D., Scientific 
Integrity Officer, Office of Science and Data Policy, Office of the 
Assistant Secretary for Planning and Evaluation, Office of the 
Secretary, HHS at 240-453-8435 or [email protected].

SUPPLEMENTARY INFORMATION: Scientific integrity plays a vital role in 
the mission of HHS. Ensuring integrity in science throughout the 
Department allows HHS to foster and produce high-quality science, 
communicate effectively with the public, and base critical policy 
decisions on trustworthy and rigorous scientific findings. HHS has 
adopted a Department-wide scientific integrity policy to further 
strengthen scientific integrity and evidence-based policymaking 
throughout the Department.
    The Scientific Integrity Policy of the U.S. Department of Health 
and Human Services (Policy) was approved on September 16, 2024. The 
finalized Policy was announced to the HHS community and posted on the 
HHS scientific integrity website, at https://www.hhs.gov/programs/research/scientificintegrity/index.html, on September 30, 2024. The 
effective date of the Policy is October 16, 2024.
    The content of the finalized Policy, reformatted to conform to the 
requirements of the Federal Register, is provided below. This content 
is also available in its original format on the HHS website, at https://www.hhs.gov/sites/default/files/hhs-scientific-integrity-policy.pdf.

The Scientific Integrity Policy of the U.S. Department of Health and 
Human Services

Purpose

    The purpose of this policy is to promote a continuing culture of 
scientific integrity at the U.S. Department of Health and Human 
Services (HHS). This policy aims to ensure the integrity of all aspects 
of HHS 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.

Core Values That Support Scientific Integrity at HHS

    The success of HHS's mission to enhance the health and well-being 
of all Americans depends on the development and use of accurate, 
complete, and timely scientific and technical information. Scientific 
integrity requires that such information be developed under and 
subjected to well-established scientific processes, free from 
inappropriate interference that undermines impartiality, 
nonpartisanship, or professional judgment. HHS agencies work to 
maximize the quality, accuracy, objectivity, utility, and timeliness of 
the scientific and technological information they produce, use, and 
disseminate. In turn, this information enables HHS to employ innovative 
approaches to effectively address the many public health and human 
services challenges that our work targets. These efforts allow 
accurate, complete, and timely scientific and technical information to 
improve the design, delivery, and impact of HHS policies and programs, 
and support equity, justice, and trust. Responsibility for upholding 
scientific integrity lies with the entire scientific ecosystem, 
including all HHS employees, its contractors and grantees, and those 
engaged in science and scientific activities outside HHS.

Definition of Scientific Integrity and Scientific Integrity Official

    HHS adopts the following Official Federal Definition of Scientific 
Integrity:

    Scientific integrity is the adherence to professional practices, 
ethical behavior, and

[[Page 92831]]

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.\1\

    HHS designates a senior career employee as the HHS Scientific 
Integrity Official (HHS SIO) \2\ to oversee implementation and 
iterative improvement of the HHS Scientific Integrity Policy and 
related processes. The roles and responsibilities of the HHS SIO are 
described in more detail on pages 17-18.
    This policy empowers the HHS SIO with the independence necessary to 
gather and protect information to support the review and assessment of 
scientific integrity concerns and ensure implementation of corrective 
scientific actions such as policy changes or correction or retraction 
of published materials. The HHS SIO also advocates for appropriate 
engagement of scientific leadership in decision making.

Effective Date and Policy Amendments

    This policy is effective 30 days after the date of finalization. 
This policy will be reviewed by HHS one year after its effective date 
and every two years thereafter. Proposals to amend this policy will be 
overseen by the HHS SIO, in collaboration with the HHS Scientific 
Integrity Council described below and communicated to the Director of 
the White House Office of Science and Technology Policy (OSTP) no later 
than 30 days after adoption.

Applicability & Scope

    Scientific integrity is the responsibility of the entire HHS 
workforce. Covered individuals who are required to adhere to this 
policy include all HHS employees, including all Operating and Staff 
Division (OpDiv/StaffDiv) employees; Public Health Service Commissioned 
Corps officers; political appointees; HHS fellows, trainees, and 
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 decision 
making.
    HHS is composed of OpDivs/StaffDivs (hereinafter ``Division''), 
some of which have division-specific scientific integrity policies and 
procedures. The HHS Scientific Integrity Policy applies to all covered 
individuals, as listed above; Division-specific Scientific Integrity 
policies apply to covered individuals within that division. Division-
specific policies align with and support the HHS-wide policy at a 
minimum but may institute additional requirements and responsibilities 
as appropriate for the mission of the division. In addition to 
Division-specific policies, Divisions may develop their own scientific 
integrity procedures (e.g., procedures for resolving differences of 
scientific opinion) at their discretion.
    HHS contractors; partners; permittees; lessees; grantees; 
extramural trainees and fellows (i.e., those supported by HHS grants to 
non-HHS organizations); and volunteers who engage or assist in HHS 
scientific activities are not considered covered individuals but are 
strongly encouraged to uphold the principles of scientific integrity 
described in this policy, particularly those described in the 
Protecting Scientific Processes, Ensuring the Free Flow of Scientific 
Information, Protections, and Professional Development sections. 
Specific requirements may be incorporated into the terms of their 
engagement with HHS. In addition, each institution that applies for or 
receives Public Health Service (PHS) support for biomedical or 
behavioral research, research training, or activities related to that 
research or research training must comply with 42 CFR part 93, PHS 
Policies on Research Misconduct, overseen by the HHS Office of Research 
Integrity (ORI), and may need to comply with other applicable laws, 
regulations, and policies. Research misconduct, which includes 
fabrication, falsification, and plagiarism, is one way in which 
scientific integrity can be compromised.

Authorities

    Pursuant to the 2021 Presidential Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based 
Policymaking,\3\ and consistent with the 2009 Presidential Memorandum 
on Scientific Integrity \4\ and the 2010 Memorandum from the White 
House Office of Science and Technology Policy on Scientific 
Integrity,\5\ 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 (SI-FTAC), Protecting 
the Integrity of Government Science \6\ (SI-FTAC Report), and align 
with the 2021 NSTC Framework for Federal Scientific Integrity Policy 
and Practice.\7\
    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 part 2635, 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. 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. 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 117-328--Health Extenders, Improving Access to Medicare, 
Medicaid, and CHIP, and Strengthening Public Health Act of 2022, 
Division FF, Title II, Section 2321

[[Page 92832]]

21. Public Law 117-167--CHIPS and Science Act of 2022, Title VI, 
Subtitle D, Section 10631

Exceptions

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

Definitions

    For the purposes of this policy, HHS adopts the following 
definitions:
    Allegation refers to a disclosure of a suspected loss of scientific 
integrity.
    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 who are required to adhere to this policy 
include all HHS employees; Public Health Service Commissioned Corps 
officers; political appointees; HHS fellows, trainees, and 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 decision 
making.
    Decision making 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.
    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 Government 
corporation, or 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, or security justification.\8\ 
\9\
    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.
    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.
    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 political 
advantage or such that it undermines impartiality, 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.\10\
    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 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.\11\ \12\
    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 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.
    Scientific record refers to published information resulting from 
scientific activities. HHS is responsible for ensuring the accuracy of 
elements of the scientific record that are published by HHS.
    Scientist refers to an individual whose responsibilities include 
collection, generation, use, or evaluation of scientific and technical 
data, analyses, or products. HHS scientists are HHS 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).

[[Page 92833]]

Policy Requirements

Promoting a Culture of Scientific Integrity

    HHS 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.
    HHS 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, and inclusive. Issues 
of diversity, equity, inclusion, and accessibility are an integral 
component of the entire scientific process. Attention to these issues 
can improve the representativeness and eminence 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.
    To instill and enhance a culture of scientific integrity, HHS has 
posted this policy prominently on its website, at https://www.hhs.gov/programs/research/scientificintegrity/index.html, and educates all 
covered individuals, as well as contractors who perform scientific 
activities for HHS, on their rights and responsibilities related to 
scientific integrity. Training will be made available to all covered 
individuals to make them aware of their responsibilities under the HHS 
Scientific Integrity Policy upon hiring, and some covered individuals 
may be required to complete role-specific training or refresher 
training as appropriate. Training will be tracked to ensure covered 
entities have received appropriate training.
    HHS 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 granting communities more autonomy over 
research questions and research design, recognition of data and 
knowledge sovereignty, and inclusion of multiple forms of evidence, 
such as Indigenous Knowledge, as applicable.
    To promote a culture of scientific integrity at HHS, 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

    Scientific integrity fosters ``honest scientific investigation, 
open discussion, refined understanding, and a firm commitment to 
evidence'' (OSTP 2010). It also enables consideration and documentation 
of differing scientific opinions. Practices that support scientific 
integrity may include peer review and open science. Science, and public 
trust in science, thrives in an environment that prevents political 
interference and inappropriate influence from impacting scientific data 
and analyses and their use in decision making.
    It is the policy of HHS to:
    1. Prohibit political interference or other inappropriate influence 
in the design, proposal, conduct, review, management, evaluation, 
communication about, and use of scientific activities and scientific 
information.
    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.
    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 to the scientific product 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. 
This policy sets a minimum requirement for authorship attribution, and 
HHS OpDivs/StaffDivs may have additional authorship criteria. Different 
scientific disciplines use a range of strategies to attribute 
scientific work to individuals, and documents may be published without 
authorship attributions.
    6. Ensure independent review of scientific facilities, 
methodologies, and other scientific activities as appropriate to ensure 
scientific integrity.
    7. Require that covered individuals comply with HHS 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.
    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 HHS 
official(s) for their determination as to whether a recusal, 
disclaimer, or other action is appropriate, consistent with HHS ethics 
policies and procedures.
    10. Require that research 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.
    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 policy, prohibit 
HHS

[[Page 92834]]

personnel engaged in intramural research from participating in foreign 
talent recruitment programs, unless 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 HHS.\13\
    13. Consistent with OSTP guidance and relevant HHS 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 HHS.\10\
    14. Prohibit the suspension or early termination of a grant except 
as consistent with applicable law and grants policies.\14\ \15\ \16\

II. Ensuring the Free Flow of Scientific Information

    Open and timely communication of HHS science plays a valuable role 
in building public trust and understanding of HHS work. HHS facilitates 
the free flow of scientific and technological information and supports 
scientific integrity in the communication of scientific activities, 
findings, and products.
    It is the policy of HHS to:
    1. Facilitate the free flow of scientific and technological 
information, to the extent permissible by federal laws and regulations. 
Consistent with open government requirements, HHS 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.\17\ \18\
    2. Ensure that scientific findings and products are not unduly 
suppressed, delayed, or altered for political purposes and are not 
subjected to inappropriate influence.
    3. 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 HHS Scientific Integrity Policy and may be 
reported under the Procedures: Addressing Scientific Integrity Concerns 
section in this document.
    4. Prohibit HHS officials, including communications officers, from 
altering, or directing HHS 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.
    5. Ensure that scientific information is accurately represented in 
responses provided by HHS to Congressional inquiries, testimony, and 
other requests.
    6. Ensure that the work and conclusions of HHS scientists and the 
work and conclusions of scientists funded or supported by the federal 
government are accurately represented in HHS 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.
    7. Accurately represent the work and conclusions of scientists in 
HHS social media communications and provide appropriate guidance to HHS 
scientists on the use of HHS social media. If scientists whose work is 
represented in HHS social media identify any errors in those 
representations, HHS social media managers are responsible for making 
appropriate corrections expeditiously.
    8. Require HHS or its OpDivs/StaffDivs, when offering spokespersons 
in response to media requests, to offer knowledgeable spokespersons who 
can, in an objective and nonpartisan manner, describe the relevant 
scientific or technological aspects of their work.
    9. Ensure that HHS scientists may communicate their scientific 
activities objectively without political interference or other 
inappropriate influence, consistent with HHS and OpDivs/StaffDivs 
communication and media policies. Scientific products must adhere to 
relevant HHS technical review procedures.
    10. Encourage, but not require, HHS scientists to communicate with 
the media in their official capacities regarding their scientific 
activities and areas of expertise, subject to limitations of government 
ethics rules.\19\ In communicating with the media, HHS scientists are 
encouraged to seek advice from career HHS communications experts.
    11. Allow covered individuals to 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.\20\ 
HHS scientists and other covered individuals presenting their personal 
views may name HHS as their employer as one biographical fact among 
several; however, their title and position cannot receive more 
prominence than any other biographical fact and they must make clear 
that they are presenting their personal and/or individual views--not 
the views of HHS--and they should not be sourced by the media as an HHS 
representative.

III. Supporting Decision Making Processes

    It is the policy of HHS 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.\21\ 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.
    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 HHS 
communication of the science upon which a policy decision is based.
    4. Ensure that the HHS SIO, with input from the HHS Scientific 
Integrity Council, develops a transparent mechanism for covered 
individuals to express differing scientific opinions free from 
political interference or inappropriate influence.

IV. Ensuring Accountability

    It is the policy of HHS to:

[[Page 92835]]

    1. Ensure correction of the scientific record and implementation of 
corrective scientific actions when allegations of a loss of scientific 
integrity are substantiated. Corrective scientific 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 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 HHS SIO, together with other Scientific 
Integrity Council members, as applicable, draft procedures to respond 
to allegations of loss of scientific integrity at HHS 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, an appeals process, follow-up to 
track implementation of remedies, and reporting. OpDivs/StaffDivs may 
develop and implement division-specific procedures for handling 
allegations within their Divisions.
    5. These procedures will document the necessary aspects for each 
step of the process including burden of proof, any necessary 
determination of intentionality, and reporting, as well as the roles of 
the HHS SIO and HHS staff in the process.
    6. Ensure that relevant HHS OpDivs/StaffDivs have scientific 
integrity policies that are consistent and in alignment with this 
policy.

V. Protections

    HHS assures the protection of covered individuals as appropriate 
from retaliation in implementation of this policy.
    It is the policy of HHS to:
    1. Select and retain candidates for 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.
    2. Promote diversity, equity, inclusion, and accessibility in the 
scientific workforce and create safe workspaces that are free from 
harassment and discrimination. Support scientists and researchers 
including, but not limited to, Black, Latino, and 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.
    3. Protect from retaliation those individuals who report in good 
faith allegations of loss of scientific integrity. Efforts will be made 
to protect the privacy of individuals involved in allegations.
    4. Prevent HHS employees from intimidating or coercing 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. 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 Corps (PHSCC) officers through 42 U.S.C. 213a(a)(18), and 
implemented by Commissioned Corps Directive (CCD) 121.06.
    6. The HHS SIO and OpDiv/StaffDiv SIOs 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.\22\ \23\

VI. Professional Development for Government Scientists

    HHS encourages its scientists and other covered individuals 
involved in HHS scientific activities to interact with the broader 
scientific community, in a manner that is consistent with Federal rules 
of ethics, employment responsibilities, and to the extent that is 
practical, given the availability of funding to support such 
interactions.\24\
    It is the policy of HHS to:
    1. Encourage timely publication of research such as in peer-
reviewed, professional, scholarly journals, HHS technical reports and 
publications or other appropriate outlets.
    2. Encourage the sharing of scientific activities, findings, and 
materials through appropriate avenues including digital repositories.
    3. Encourage participation in and presentation of research at 
professional meetings including workshops, conferences, and symposia.
    4. When appropriate, permit service on editorial boards, as peer 
reviewers, or as editors of professional or scholarly journals.
    5. When appropriate, permit participation 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.
    6. Permit government 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 HHS 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)

    Federal Advisory Committees (FACs), as defined by the Federal 
Advisory Committee Act, 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 HHS for ensuring the credibility, quality, and transparency of 
HHS science. HHS will adhere to the Federal Advisory Committee Act 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.

[[Page 92836]]

    Consistent with all applicable laws and guidance regarding FACs, it 
is the policy of HHS 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. 
Additional factors that may be considered are availability of the 
member to serve, alignment with relevant Federal Advisory Committee 
Membership Balance Plan, and the ability to work effectively on 
advisory committees. Ensure committee membership is fairly balanced in 
terms of points of view represented with respect to the functions to be 
performed by the FAC.\25\
    3. Comply with current standards governing conflict of interest as 
defined in statutes and implementing regulations.
    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.

Scientific Integrity Council

    HHS will establish a Scientific Integrity Council (Council) 
comprising one senior career employee from each relevant HHS OpDiv/
StaffDiv. Relevant HHS divisions include those that conduct, manage, 
use, and communicate about scientific activities, as defined by the HHS 
Scientific Integrity Policy. The Council may engage with other HHS 
divisions as needed to support its responsibilities. The Council will 
be chaired by the HHS SIO. Where an OpDiv/StaffDiv has established a 
division SIO, that person will represent the division; where an OpDiv/
StaffDiv has not established a division SIO, a similarly high-ranking 
career official with the appropriate scientific expertise, stature, and 
authority will represent the division.
    Council members will ensure consistent implementation of the 
Scientific Integrity Policy at HHS, act as liaisons for their 
respective OpDivs/StaffDivs, assist with training and policy 
assessment, updates, and amendments, and be available to address any 
questions or concerns regarding this policy. The HHS SIO, together with 
the Council, will draft a Scientific Integrity Council Charter 
outlining criteria for selection as a member, other duties of members, 
and the frequency of meetings. The primary responsibilities of the 
Council are to:
    1. Ensure that a well-informed and high-level group of experts 
supports scientific integrity at HHS.
    2. Ensure that the HHS Scientific Integrity Policy is implemented 
consistently across the Department.
    3. Review, assess, and revise the HHS Scientific Integrity Policy 
every two years, or more frequently as needed.
    4. Serve on scientific integrity review panels and adjudicate 
allegations of losses of scientific integrity originating at HHS 
divisions that do not have their own scientific integrity policy, 
originating from more than one HHS division, or originating within the 
Office of the Secretary.
    5. Determine handling of investigation and adjudication proceedings 
from which the HHS SIO is recused.
    6. Engage HHS and division leadership in upholding the principles 
of scientific integrity, and maintain leadership awareness of 
scientific integrity issues as necessary and appropriate.
    7. Support the education of all Department employees on their 
rights and responsibilities related to scientific integrity.

Procedures

    The HHS SIO, in conjunction with the Scientific Integrity Council, 
has developed the following procedures for addressing scientific 
integrity concerns, handling differing scientific opinions, and 
clearance of scientific products and communications.

Addressing Scientific Integrity Concerns

    The HHS SIO has primary responsibility for addressing scientific 
integrity concerns raised to the Department. The Scientific Integrity 
Council will support and assist the HHS SIO as needed. Full policies 
and procedures for handling scientific integrity concerns will be made 
available on the HHS website, at https://www.hhs.gov/programs/research/scientificbintegrity/index.html. HHS OpDivs/StaffDivs may have their 
own procedures for addressing scientific integrity concerns that arise 
in their own divisions. For information about rights and remedies 
against retaliation, employees may contact the HHS OIG Whistleblower 
Protection Coordinator.\26\ In general:
    1. Concerns about a potential loss of scientific integrity at HHS 
may be reported to the HHS SIO by any individual who has knowledge of 
the situation. Reporting may be done anonymously.
    2. Employees of HHS or its OpDivs/StaffDivs are encouraged to seek 
an informal consultation with the HHS SIO or the relevant division SIO 
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. If an OpDiv/StaffDiv has its own procedures in place for 
handling scientific integrity concerns, formal complaints submitted to 
HHS that involve actions and outcomes specific to that division will be 
directed to that division for follow up. For divisions without their 
own procedures, formal complaints will be handled by the HHS Scientific 
Integrity Council.
    4. The HHS SIO, with the help of the Scientific Integrity Council 
as needed, will complete 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.
    5. Should an investigation be opened, an investigation committee 
consisting of the HHS SIO and at least two other Scientific Integrity 
Council members, or their delegates, will be convened. The committee 
will develop a factual record by exploring the allegation(s) in detail 
and consulting with subject matter experts, interviewing witnesses, and 
reviewing documentation as needed. This record will be documented in a 
report from the committee to the HHS SIO.
    6. Once the investigation is complete and a report has been 
submitted to the HHS SIO, the HHS SIO will determine whether scientific 
integrity was lost, and if so, what corrective scientific actions are 
recommended.
    7. 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

[[Page 92837]]

violating scientific integrity, and HHS encourages its scientists to 
respectfully express and engage with differing views as an integral 
part of the scientific process. 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. HHS OpDivs/StaffDivs may have 
dispute resolution policies in place; employees of these divisions must 
follow any such policies and guidelines. If a division does not have a 
dispute resolution process already in place, the following steps may be 
used as a guide. These steps may be completed in any order and are not 
necessarily an exhaustive list of dispute resolution measures. In 
general:
     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. HHS 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 their division's SIO. The HHS 
SIO may be consulted if the division SIO requests their assistance, if 
there is no division SIO, or if there is a conflict of interest or 
perceived conflict of interest with the division SIO. The HHS SIO will 
review the dispute history and may recommend additional internal 
discussion, peer review, or involvement of subject matter experts. The 
HHS SIO may also serve as a mediator or engage the services of a 
professional mediator to help end the dispute. The HHS SIO acting in 
this capacity serves to uphold scientific integrity and will not 
advocate for a particular scientific position.

Roles and Responsibilities

    Scientific Integrity is everyone's responsibility. The following 
individuals have specific scientific integrity roles and 
responsibilities under this policy:

I. The Secretary of Health and Human Services

    1. Provides leadership for HHS on scientific integrity, by leading 
through example, upholding scientific integrity principles, and 
regularly communicating the importance of scientific integrity.
    2. Ensures that all HHS activities associated with scientific and 
technological processes are conducted in accordance with this policy.
    3. Ensures that all supervisors and managers comply with this 
policy and ensures accountability for those who do not.
    4. Ensures that violations of this policy are investigated to the 
full extent that is described herein, and that appropriate corrective 
scientific and/or administrative actions are taken as a result of such 
investigations.
    5. Ensures that HHS scientific integrity efforts support HHS plans 
for making evidence-based policies, including the evidence-building 
plans required by 5 U.S.C. 312(a) and the annual evaluation plans 
required by 5 U.S.C. 312(b).
    6. Provides adequate resources and funding to implement this policy 
including staffing, monitoring, evaluation, reporting, and training.
    7. Ensures that SIOs are afforded all applicable career employee 
rights and appeals and are protected against retaliation of any kind.
    8. Supports and respects the HHS SIO's independence, 
recommendations, and designation of and HHS compliance with corrective 
scientific actions when violations of this policy are substantiated. 
Assistance may be sought from the National Science and Technology 
Council (NSTC) Subcommittee on Scientific Integrity (SOSI) in cases of 
disagreement.
    9. In cooperation with the HHS SIO, oversees the implementation and 
iterative improvement of policies and processes affecting the integrity 
of scientific activities funded, conducted, or overseen by HHS, as well 
as policies affecting the Federal and non-Federal scientists who 
support the scientific activities of HHS, including scientific-
integrity policies.
    10. Ensures that HHS establishes as necessary clear administrative 
actions for substantiated violations of this policy, designating 
responsibility for each aspect of accountability.

II. HHS Scientific Integrity Official

    1. Is a designated, full-time equivalent, career employee who holds 
a permanent appointment and has appropriate scientific credentials and 
is designated at a senior level.
    2. Oversees implementation and iterative improvement of scientific-
integrity policies and processes, provides leadership on matters of 
scientific integrity, and serves as the primary HHS-level contact for 
questions regarding scientific integrity.
    3. Leads training and outreach initiatives to facilitate employee 
awareness and understanding of this policy.
    4. Serves as a neutral point of contact for receiving allegations 
of loss of scientific integrity, provides informal consultation for 
employees who have scientific integrity concerns, and adheres to 
privacy and confidentiality policies, as applicable.
    5. Conducts an initial assessment of all formal complaints and 
submitted materials, following established procedures, to determine 
whether the allegations pertain to loss of scientific integrity and the 
appropriate handling of said allegations. Provides independent 
oversight of HHS responses to allegations of loss of scientific 
integrity referred for an inquiry or investigation, including:
    a. Reviewing HHS-submitted reports of allegations and their 
disposition.
    b. Maintaining a status report of responses to allegations as a 
means of monitoring the progress toward resolution.
    6. Leads efforts to update this policy and any accompanying 
guidance, as appropriate.
    7. Reports to the HHS Deputy Assistant Secretary for Science and 
Data Policy on matters involving scientific integrity.
    8. Coordinates as necessary with the HHS Offices of Research 
Integrity (ORI), Human Research Protections (OHRP), Inspector General 
(OIG), the General Counsel (OGC), Human Resources, Civil Rights, the 
Assistant Secretary for Public Affairs, and the Chief Information 
Officer, among others.
    9. Reports any potentially criminal behavior related to waste, 
fraud, abuse, or potential employee misconduct to OIG that is uncovered 
while responding to an allegation of loss of scientific integrity and 
coordinates as appropriate related to the referral provided to OIG.
    10. Keeps the HHS Secretary informed on the status of the 
implementation of this policy and any compliance concerns, as 
warranted.
    11. Publishes an annual scientific integrity report as described 
below.

[[Page 92838]]

    12. Leads efforts for the iterative improvement of this policy and 
scientific integrity initiatives overall including development and 
implementation of an evaluation plan to regularly monitor and evaluate 
ongoing scientific integrity activities and outcomes.
    13. To the extent possible, is involved in high level discussions 
and strategic planning on the recruitment, retention, development, and 
advancement of scientists--including scientists from underrepresented 
communities--to help ensure that scientific integrity is appropriately 
and carefully considered.

III. HHS Scientific Integrity Council Members

    1. As delegated by the HHS SIO, oversees implementation and 
iterative improvement of scientific integrity policies and processes.
    2. Coordinates with the HHS SIO in implementing scientific-
integrity policies and processes.
    3. Provides oversight for the implementation of the Scientific 
Integrity Policy at HHS.
    4. Acts as liaisons for their respective HHS OpDivs/StaffDivs.
    5. Assists with training and policy assessment, updates, and 
amendments.
    6. Is available to address any questions or concerns regarding this 
policy.
    7. Other duties as delegated.

IV. HHS Managers and Supervisors

    1. Comply with and ensure HHS and employee compliance with the 
scientific integrity policy, including reporting or advising others on 
reporting allegations of loss of scientific integrity.
    2. Make themselves aware of and uphold the principles contained in 
this policy. Lead through example by upholding scientific integrity 
principles and communicating the importance of doing so.
    3. Report any knowledge of potential loss of scientific integrity 
to the HHS SIO or OpDiv/StaffDiv scientific integrity officials without 
reprisal.
    4. Consult, as appropriate, with the HHS SIO or relevant OpDiv/
StaffDiv SIOs, human resources officers, contracting and grant 
personnel, ethics officers, ORI, OIG, OGC, and the Office for Civil 
Rights.

V. HHS Employees and Other Covered Individuals

    1. Make themselves aware of the principles contained in this policy 
and how the policy applies to their duties.
    2. Comply with this policy.
    3. Adhere to accepted professional values and practices of the 
relevant research/scientific communities to which they belong.
    4. Are encouraged to report to the HHS SIO or OpDiv/StaffDiv SIO 
any concern of loss of scientific integrity and are encouraged to 
report retaliation or potential criminal activity to the HHS OIG 
Hotline.\27\

Monitoring and Evaluating Scientific Integrity Activities and Outcomes

    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 SI processes, procedures, and policies. The plan will 
include expected metrics and measurement methods for evaluating the HHS 
Scientific Integrity Policy; workforce training; scientific integrity 
leadership, staffing, and communication; and reporting mechanisms. As 
part of the monitoring and evaluation plan, HHS will publish an annual 
report on the number and outcomes of investigations and appeals 
involving allegations of loss of scientific integrity. To the extent 
possible, all descriptions of investigations and appeals will be 
anonymized.
    The plan shall also include a timeline for implementation and 
frequency of data collection, analysis, review, recommendations, and 
implementing recommendations. Monitoring and evaluation results, 
recommendations, and policy/procedure changes based on results will be 
reported to HHS leadership and will be made available to HHS staff and 
the public in a timely manner.

Reporting

    The HHS SIO, with input from the Scientific Integrity Council, is 
responsible for developing and making prominently available on HHS's 
public facing website, at https://www.hhs.gov/programs/research/scientificintegrity/index.html, an annual report to HHS leadership on 
the status of scientific integrity within HHS. The report shall 
highlight scientific integrity successes, accomplishments, or progress 
across HHS and identify areas for improvement and plans for addressing 
critical weaknesses, if any. The report shall describe progress toward 
achieving key metrics, including comparisons to the same metrics from 
prior years to show trends over time, whenever feasible. It will also 
include the number of investigations and appeals involving alleged or 
actual violations of this scientific integrity policy, including 
pending investigations and appeals. 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.

Related Policies and Statutes

    Involving SIOs at HHS and its OpDivs/StaffDivs in the writing and 
updating of related policies can help provide needed perspectives 
before such policies are issued and better ensure they support 
scientific integrity. Officials should consider the scientific 
integrity-related components of other policies (e.g., professional 
development of scientists, science-related communications, etc.) and 
determine where those other policies should be referenced, or perhaps 
reinforced, within the agency scientific integrity policy to help 
ensure their longevity. Violations of related and supporting policies 
may result in a loss of scientific integrity and it is appropriate for 
SIOs to coordinate with their agency counterparts in these matters.
    SIOs should have an awareness of policies and programs that 
intersect with the development of the culture of scientific integrity 
within the agency. SIOs, where possible, shall be involved in the 
development or revision of the broader set of policies and practices 
that affect the culture and applicability of scientific integrity 
within HHS.

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.federalregister.gov/d/05-9643

Diversity, Equity, Inclusion, and Accessibility (DEIA) 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/index.html
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-

[[Page 92839]]

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

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. part 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/index.html#:~:text=Consent%20Posting%20Guidance-
,Federal%20Policy%20for%20the%20Protection%20of%20Human%20Subjects%20('C
ommon,of%20Biomedical%20and%20Behavioral%20Research.
FDA Policy for the Protection of Human Subjects: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fda-policy-protection-human-subjects
Animal Welfare Act and Regulations: https://www.aphis.usda.gov/animal_welfare/downloads/bluebook-ac-awa.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

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. part 2302--Prohibited personnel practices: https://uscode.house.gov/view.xhtml?req=29&f=treesort&num=125
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
Whistleblower Protection Enhancement Act of 2012: https://www.congress.gov/112/statute/STATUTE-126/STATUTE-126-Pg1465.pdf
41 U.S.C. part 4712--Enhancement of contractor protection from reprisal 
for disclosure of certain information: https://uscode.house.gov/view.xhtml?req=(title:41%20section:4712%20edition:prelim)
Presidential Policy Directive 19--Protecting Whistleblowers with Access 
to Classified Information: https://www.usda.gov/sites/default/files/documents/ppd.pdf
US Office of Special Counsel: https://osc.gov/
10 U.S.C. part 1034, made applicable to the Public Health Service 
Commissioned Corps through 42 U.S.C. 213a(a)(18), and implemented by 
Commissioned Corps Directive (CCD) 121.06: https://dcp.psc.gov/ccmis/
ccis/documents/
CCD121_06.pdf#:~:text=CCD%20121.06%20EFFECTIVE%20DATE%3A%2010%20February
%202022%20By,and%20Human%20Services%3A%20Xavier%20Becerra%20SUBJECT%3A%2
0Protected%20Communications
Foundations for Evidence-Based Policymaking Act (``Evidence Act''): 
https://www.congress.gov/bill/115th-congress/house-bill/4174/text
Notification and Federal Employee Antidiscrimination and Retaliation 
Act (``No FEAR Act''): https://www.govinfo.gov/content/pkg/PLAW-107publ174/html/PLAW-107publ174.htm
Dual Use Research of Concern: https://www.phe.gov/s3/dualuse/documents/durc-policy.pdf
The Federal Advisory Committee Act: https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act
Paperwork Reduction Act: https://www.govinfo.gov/content/pkg/PLAW-104publ13/html/PLAW-104publ13.htm
HHS Grants Policy Statement: https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf
ASPA's Guidelines on the Provision of Information to the News Media: 
https://www.hhs.gov/sites/default/files/media_policy.pdf

Endnotes

    \1\ Guidance by the Scientific Integrity Framework Interagency 
Working Group of the National Science and Technology Council ``A 
Framework for Federal Scientific Integrity Policy and Practice.'' 
January 12, 2023. Available at: https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf.
    \2\ Some HHS Operating and Staff Divisions have or may designate 
their own Scientific Integrity Officials. This document uses ``HHS 
SIO'' to refer to the official designated by HHS to coordinate 
department-wide implementation of this Policy and ``SIO'' to refer 
to all Scientific Integrity Officials, including those at Operating 
and Staff Divisions.
    \3\ Presidential Memorandum on Restoring Trust in Government 
Through Scientific Integrity and Evidence-Based Policy Making, 
January 27, 2021. Available 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/.
    \4\ Presidential Memorandum for the Heads of Executive 
Departments and Agencies on Scientific Integrity. March 9, 2009. The 
White House. Available at: https://obamawhitehouse.archives.gov/the-press-office/memorandum-heads-executive-departments-and-agencies-3-9-09.
    \5\ Presidential Memorandum for the Heads of Executive 
Departments and Agencies on Scientific Integrity. December 17, 2010. 
Office of Science and Technology Policy. Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf.
    \6\ 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.
    \7\ Guidance by the Scientific Integrity Framework Interagency 
Working Group of the National Science and Technology Council ``A 
Framework for Federal Scientific Integrity Policy and Practice.'' 
January 12, 2023. Available at: https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf.
    \8\ Examples may include (1) suppressing a decisionmaker's 
ability to offer the best judgment based on scientific information; 
(2)

[[Page 92840]]

preventing the use of best available science; (3) insisting on 
preclearance of a scientific product for purposes other than 
providing advance notification or opportunity to review for 
technical merit; (4) suppressing, altering or delaying the release 
of a scientific product for any reason other than technical merit or 
providing advance notification; (5) removing or reassigning 
scientific personnel for any reason other than performance, conduct 
or budgetary constraints; (6) 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 (7) misrepresenting the underlying 
assumptions, uncertainties, or probabilities of scientific products. 
This is not intended to be an exhaustive list.
    \9\ Differences of scientific opinion are not necessarily 
inappropriate influence.
    \10\ See Federal Research Misconduct Policy, 65 FR 76260, 76262 
(Dec. 6, 2000); see also https://ori.hhs.gov/definition-research-misconduct.
    \11\ Public Law 112-199 Sec.  110.
    \12\ 5 U.S.C. 2302(b)(8).
    \13\ See 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.
    \14\ HHS Grants Policy Statement, U.S. Department of Health and 
Human Services, Office of the Assistant Secretary for Resources and 
Technology, Office of Grants. January 1, 2007. Available at: https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
    \15\ HHS Grants Policy Administration Manual Version 1.02. 
November 13, 2023.
    \16\ 45 CFR 75.372.
    \17\ Presidential Memorandum for the Heads of Executive 
Departments and Agencies on Increasing Access to the Results of 
Federally Funded Scientific Research. Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf.
    \18\ Presidential Memorandum for the Heads of Executive 
Departments and Agencies on Ensuring Free, Immediate, and Equitable 
Access to Federally Funded Research. Available at: https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf.
    \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/
$FILE/LA-23-
03%20The%20Standards%20of%20Conduct%20and%2018%20U.S.C.%20%C2%A7%2020
8%20as%20Applied%20to%20Official%20Social%20Media%20Use.pdf.
    \20\ Memorandum to Designated Agency Ethics Officials on The 
Standards of Conduct as Applied to Personal Social Media Use. 
Available at: https://www.oge.gov/web/oge.nsf/0/
195DAE83D38EF6A9852585BA005BEC69/$FILE/LA-15-03-2.pdf.
    \21\ 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.
    \22\ 5 U.S.C. 7513, 4303.
    \23\ Commissioned Corps Directive 111.02.
    \24\ Subject to the limitations and requirements as to 
participation in foreign talent programs outlined in I.12-13 of this 
policy.
    \25\ 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.
    \26\ See https://oig.hhs.gov/fraud/whistleblower/. Employees can 
also contact their OpDiv/StaffDiv's office of Equal Employment 
Opportunity (``EEO'') for information regarding retaliation based on 
protected EEO activity or discrimination, or the Office of Special 
Counsel for information regarding retaliation based on 
whistleblowing. 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. PHSCC officers 
should also refer to CCD 121.06, ``Protected Communications,'' CCD 
111.01, ``Equal Opportunity,'' and CCI 211.03, ``Equal 
Opportunity.''
    \27\ https://oig.hhs.gov/fraud/report-fraud/before-you-submit/.

    Dated: October 28, 2024.
Katherine N. Bent,
Associate Deputy Assistant Secretary, Office of Science and Data 
Policy, Office of the Assistant Secretary for Planning and Evaluation, 
Department of Health and Human Services.
[FR Doc. 2024-25810 Filed 11-22-24; 8:45 a.m.]
BILLING CODE 4150-05-P
```