Rule2024-25810
Final Scientific Integrity Policy
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 25, 2024
Effective
October 16, 2024
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services (HHS) is publishing its Scientific Integrity Policy to increase access to and raise awareness of the Policy.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-25810]
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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.
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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 <a href="/cdn-cgi/l/email-protection#c5b6a6aca0abb1aca3aca6acabb1a0a2b7acb1bc85adadb6eba2aab3"><span class="__cf_email__" data-cfemail="0f7c6c666a617b6669666c66617b6a687d667b764f67677c21686079">[email protected]</span></a>.
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 <a href="https://www.hhs.gov/programs/research/scientificintegrity/index.html">https://www.hhs.gov/programs/research/scientificintegrity/index.html</a>, 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 <a href="https://www.hhs.gov/sites/default/files/hhs-scientific-integrity-policy.pdf">https://www.hhs.gov/sites/default/files/hhs-scientific-integrity-policy.pdf</a>.
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 <a href="https://www.hhs.gov/programs/research/scientificintegrity/index.html">https://www.hhs.gov/programs/research/scientificintegrity/index.html</a>, 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 <a href="https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act">https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act</a>, are an important tool
within 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 <a href="https://www.hhs.gov/programs/research/scientificbintegrity/index.html">https://www.hhs.gov/programs/research/scientificbintegrity/index.html</a>. 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:
<bullet> A team member or group of team members with a differing
opinion may engage with their colleagues to resolve the issue as soon
as the difference of opinion is known. HHS recommends this type of
internal discussion as a first step in most dispute resolution
proceedings.
<bullet> A team may choose to consult a manager. First-level
managers may defer to an appropriate higher-level manager if the first-
level manager has a conflict of interest or cannot offer an impartial
opinion for any reason.
<bullet> If the matter cannot be satisfactorily resolved by other
means, a team may request assistance from 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 <a href="https://www.hhs.gov/programs/research/scientificintegrity/index.html">https://www.hhs.gov/programs/research/scientificintegrity/index.html</a>, 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: <a href="https://www.federalregister.gov/documents/2000/12/06/00-30852/executive-office-of-the-president-federal-policy-on-research-misconduct-preamble-for-research">https://www.federalregister.gov/documents/2000/12/06/00-30852/executive-office-of-the-president-federal-policy-on-research-misconduct-preamble-for-research</a>
Public Health Service Policies on Research Misconduct: <a href="https://www.federalregister.gov/d/05-9643">https://www.federalregister.gov/d/05-9643</a>
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: <a href="https://www.hhs.gov/about/agencies/asa/eeo/policy/index.html">https://www.hhs.gov/about/agencies/asa/eeo/policy/index.html</a>
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: <a href="https://www.hhs.gov/sites/default/files/2022-hhs-deia-strategic-plan.pdf">https://www.hhs.gov/sites/default/files/2022-hhs-deia-strategic-plan.pdf</a>
Public Access
NIH Public Access Policy: <a href="https://publicaccess.nih.gov/policy.htm">https://publicaccess.nih.gov/policy.htm</a>
OSTP Memorandum on Increasing Access to the Results of Federally Funded
Research (2013): <a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf</a>
OSTP Memorandum on Ensuring Free, Immediate, and Equitable Access to
Federally Funded Research (2022): <a href="https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf</a>
5 U.S.C. part 552--Freedom of Information Act: <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-5">https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-5</a>
Human and Animal Subject Protections
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: <a href="https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fda-policy-protection-human-subjects">https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fda-policy-protection-human-subjects</a>
Animal Welfare Act and Regulations: <a href="https://www.aphis.usda.gov/animal_welfare/downloads/bluebook-ac-awa.pdf">https://www.aphis.usda.gov/animal_welfare/downloads/bluebook-ac-awa.pdf</a>
Public Health Service Policy on Humane Care and Use of Laboratory
Animals: <a href="https://olaw.nih.gov/policies-laws/phs-policy.htm">https://olaw.nih.gov/policies-laws/phs-policy.htm</a>
Guide for the Care and Use of Laboratory Animals: <a href="https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf">https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf</a>
Research Security
National Security Presidential Memorandum 33 (NSPM 33): <a href="https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-united-states-government-supported-research-development-national-security-policy/">https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-united-states-government-supported-research-development-national-security-policy/</a>
Guidance for Implementing NSPM 33: <a href="https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf</a>
Whistleblower Protections
5 U.S.C. part 2302--Prohibited personnel practices: <a href="https://uscode.house.gov/view.xhtml?req=29&f=treesort&num=125">https://uscode.house.gov/view.xhtml?req=29&f=treesort&num=125</a>
Whistleblower Protection Act of 1989: <a href="https://www.govinfo.gov/content/pkg/STATUTE-103/pdf/STATUTE-103-Pg16.pdf">https://www.govinfo.gov/content/pkg/STATUTE-103/pdf/STATUTE-103-Pg16.pdf</a>
Public Law 103-424--Expansion of Whistleblower Protection Act of 1989:
<a href="https://www.govinfo.gov/content/pkg/STATUTE-108/pdf/STATUTE-108-Pg4361.pdf#page=3">https://www.govinfo.gov/content/pkg/STATUTE-108/pdf/STATUTE-108-Pg4361.pdf#page=3</a>
Whistleblower Protection Enhancement Act of 2012: <a href="https://www.congress.gov/112/statute/STATUTE-126/STATUTE-126-Pg1465.pdf">https://www.congress.gov/112/statute/STATUTE-126/STATUTE-126-Pg1465.pdf</a>
41 U.S.C. part 4712--Enhancement of contractor protection from reprisal
for disclosure of certain information: <a href="https://uscode.house.gov/view.xhtml?req=">https://uscode.house.gov/view.xhtml?req=</a>(title:41%20section:4712%20edition:prelim)
Presidential Policy Directive 19--Protecting Whistleblowers with Access
to Classified Information: <a href="https://www.usda.gov/sites/default/files/documents/ppd.pdf">https://www.usda.gov/sites/default/files/documents/ppd.pdf</a>
US Office of Special Counsel: <a href="https://osc.gov/">https://osc.gov/</a>
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''):
<a href="https://www.congress.gov/bill/115th-congress/house-bill/4174/text">https://www.congress.gov/bill/115th-congress/house-bill/4174/text</a>
Notification and Federal Employee Antidiscrimination and Retaliation
Act (``No FEAR Act''): <a href="https://www.govinfo.gov/content/pkg/PLAW-107publ174/html/PLAW-107publ174.htm">https://www.govinfo.gov/content/pkg/PLAW-107publ174/html/PLAW-107publ174.htm</a>
Dual Use Research of Concern: <a href="https://www.phe.gov/s3/dualuse/documents/durc-policy.pdf">https://www.phe.gov/s3/dualuse/documents/durc-policy.pdf</a>
The Federal Advisory Committee Act: <a href="https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act">https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act</a>
Paperwork Reduction Act: <a href="https://www.govinfo.gov/content/pkg/PLAW-104publ13/html/PLAW-104publ13.htm">https://www.govinfo.gov/content/pkg/PLAW-104publ13/html/PLAW-104publ13.htm</a>
HHS Grants Policy Statement: <a href="https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf">https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf</a>
ASPA's Guidelines on the Provision of Information to the News Media:
<a href="https://www.hhs.gov/sites/default/files/media_policy.pdf">https://www.hhs.gov/sites/default/files/media_policy.pdf</a>
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: <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf">https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf</a>.
\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: <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/">https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/</a>.
\4\ Presidential Memorandum for the Heads of Executive
Departments and Agencies on Scientific Integrity. March 9, 2009. The
White House. Available at: <a href="https://obamawhitehouse.archives.gov/the-press-office/memorandum-heads-executive-departments-and-agencies-3-9-09">https://obamawhitehouse.archives.gov/the-press-office/memorandum-heads-executive-departments-and-agencies-3-9-09</a>.
\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: <a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf</a>.
\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: <a href="https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf</a>.
\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: <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf">https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf</a>.
\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 <a href="https://ori.hhs.gov/definition-research-misconduct">https://ori.hhs.gov/definition-research-misconduct</a>.
\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: <a href="https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf">https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf</a>.
\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: <a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf</a>.
\18\ Presidential Memorandum for the Heads of Executive
Departments and Agencies on Ensuring Free, Immediate, and Equitable
Access to Federally Funded Research. Available at: <a href="https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf</a>.
\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: <a href="https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review">https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review</a>.
\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: <a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf</a>.
\26\ See <a href="https://oig.hhs.gov/fraud/whistleblower/">https://oig.hhs.gov/fraud/whistleblower/</a>. 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\ <a href="https://oig.hhs.gov/fraud/report-fraud/before-you-submit/">https://oig.hhs.gov/fraud/report-fraud/before-you-submit/</a>.
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
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