106526 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

period to an amount less than 0.5. See 

66 FR 12940. 

CMS GME Final Regulation Change 

In August 2022, CMS finalized a new 

methodology for applying the direct 

GME FTE resident cap when a hospital’s 

weighted allopathic and osteopathic 

FTE resident count is greater than its 

direct GME FTE resident cap, in a way 

that does not reduce the weighting 

factor of residents that are beyond their 

initial residency period to an amount 

less than 0.5. Under the new method, if 

a hospital’s unweighted allopathic and 

osteopathic FTE resident count exceeds 

its direct GME FTE resident cap, then 

the weighted allopathic and osteopathic 

FTE resident count is equal to the 

hospital’s direct GME FTE resident cap 

or its actual weighted allopathic and 

osteopathic FTE resident count, 

whichever is lesser. The direct GME 

FTE resident cap reflects the maximum 

number of allopathic and osteopathic 

residents that a hospital may count for 

purposes of direct GME payment in a 

cost reporting period. 

Alignment of CHGME and Medicare 

GME Policy 

For more than two decades, HRSA has 

followed CMS’s approach to calculating 

the FTE resident count. [See March 1, 

2001, Federal Register Notice (66 FRN 

12940), ‘‘The Department follows 

Medicare rules regarding the use of the 

initial residency period. The Medicare 

rules reduce counts for all hospitals that 

train residents beyond their initial 

residency period (i.e., fellows) with 

regard to the [direct medical education] 

DME and [indirect Medical Education] 

IME portions of the GME 

reimbursement.’’] Therefore, HRSA 

proposes to adopt CMS’s modified 

direct GME payment methodology with 

respect to determining the weighted 

number of allopathic and osteopathic 

FTE residents (i.e., fellows) for all 

eligible children’s hospitals 

participating in the CHGME Payment 

Program beginning in FY 2026. 

In this notice, we refer to the FTE 

adjusted cap (or 2013 CHGME 

Reauthorization cap pursuant to Pub. L. 

113–98) reported on Line 4.06, 5.06, and 

6.06 of the HRSA 99–1 Form as the 

‘‘direct GME FTE resident cap’’ to 

correspond with CMS terminology. 

HRSA proposes to modify its 

methodology to adopt the CMS 

methodology described in the amended 

42 CFR 413.79 in whole. HRSA 

anticipates implementing the updated 

methodology for determining the 

weighted allopathic and osteopathic 

FTE resident count starting in the FY 

2026 application cycle (project period 

October 1, 2025, through September 30, 

2026). 

Direct GME Methodology in FY 2026— 

Proposal for Public Comment 

Starting in FY 2026, where a CHGME 

participating hospital’s unweighted 

allopathic and osteopathic FTE resident 

count exceeds the hospital’s FTE 

resident cap, and the weighted 

allopathic and osteopathic FTE resident 

count also exceeds that FTE resident 

cap, the respective weighted allopathic 

and osteopathic FTE resident count is 

adjusted to make the total weighted 

allopathic and osteopathic FTE resident 

count equal the FTE resident cap. If the 

weighted allopathic and osteopathic 

FTE resident count does not exceed that 

FTE resident cap, then the allowable 

weighted allopathic and osteopathic 

FTE resident count for direct GME 

payment is the actual weighted 

allopathic and osteopathic FTE resident 

count. 

This proposed update to the 

methodology for determining the 

weighted allopathic and osteopathic 

FTE resident count for the CHGME 

Program is intended to reconcile 

weighted FTE resident counts reported 

in Lines 4.13 (both Hospital Data 

columns), 5.13, and 6.13 of the HRSA 

Form 99–1 with Lines 9 and 22 of the 

CMS Form 2552–10, Worksheet E–4, 

respectively. Entries in Lines 4.13 (both 

Hospital Data columns), 5.13, and 6.13 

report the weighted resident FTE count 

for allopathic and osteopathic programs 

following application of the direct GME 

FTE resident cap. 

This updated methodology for 

determining weighted allopathic and 

osteopathic FTE resident count may 

result in adjustments to the weighted 

FTE resident 3-year rolling average used 

to determine direct medical education 

(DME) payment amounts for the eligible 

children’s hospitals participating in the 

CHGME Payment Program. 

The DME payment amounts for 

CHGME are impacted by many factors 

including the number of residents the 

hospital trained during the year, the 

hospital’s wage index, as well as the 

overall appropriation. The updated 

methodology for determining the 

weighted FTE resident count will 

impact awardees that add more 

residents and fellows above their 

hospital’s direct GME FTE resident cap. 

The updated methodology may also 

impact the DME payments for awardees 

overall as a hospital may receive a 

different relative share of the CHGME 

appropriation due to these shifts in the 

weighted FTE resident counts 

experienced by some hospitals. 

The CHGME Payment Program 

proposes to implement this updated 

methodology beginning in FY 2026 to 

reduce burden on hospitals 

participating in CHGME and Medicare 

GME and to reduce the risk of potential 

audit discrepancies that may impact 

payments. 

Diana Espinosa, 

Principal Deputy Administrator. 

[FR Doc. 2024–31240 Filed 12–27–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Final Scientific Integrity Policy of the 

U.S. Department of Health and Human 

Services 

AGENCY: Office of the Assistant 

Secretary for Planning and Evaluation, 

Office of the Secretary, HHS. 

ACTION: Notice of final policy. 

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 scientificintegrity@hhs.gov. 

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 


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provided below. This content is also 

available in its original format on the 

HHS website, at https://www.hhs.gov/ 

sites/default/files/hhs-scientificintegrity-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 

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 No 111–358—The America 

COMPETES Reauthorization Act of 2010, 

Section 103, as amended. 

2. Public Law No 115–435—The Foundations 


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for Evidence-based Policymaking Act of 

2018. 

3. Public Law No 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. Pub. L. 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. Pub. L. No 117–328—Health Extenders, 

Improving Access to Medicare, 

Medicaid, and CHIP, and Strengthening 

Public Health Act of 2022, Division FF, 

Title II, Section 2321. 

21. Pub. L. No 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 wellaccepted 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 


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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 wellaccepted 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 nonscientific roles (e.g., policymakers, 

communicators). 

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 prioritysetting 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 


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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 

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. 


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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: 

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 divisionspecific 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 


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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/federaladvisory-committee-management/ 

legislation-and-regulations/the-federaladvisory-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. 

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/ 

scientificintegrity/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 


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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 

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 scientificintegrity 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 scientificintegrity policies and processes, 

provides leadership on matters of 

scientific integrity, and serves as the 

primary HHS-level contact for questions 

regarding scientific integrity. 


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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. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106535 

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-presidentfederal-policy-on-researchmisconduct-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-toAdvance-Diversity-Equity-Inclusionand-Accessibility-in-the-FederalWorkforce-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/wpcontent/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/subtitleA/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%20

the%20Protection%20of%20

Human%20Subjects%20(‘Common,

of%20Biomedical%20and

%20Behavioral%20Research 

FDA Policy for the Protection of Human 

Subjects: https://www.fda.gov/ 

science-research/clinical-trials-andhuman-subject-protection/fda-policyprotection-human-subjects 

Animal Welfare Act and Regulations: 

https://www.aphis.usda.gov/animal_

welfare/downloads/bluebook-acawa.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-forthe-care-and-use-of-laboratoryanimals.pdf 

Research Security 

National Security Presidential 

Memorandum 33 (NSPM 33): https:// 

trumpwhitehouse.archives.gov/

presidential-actions/presidentialmemorandum-united-statesgovernment-supported-researchdevelopment-national-security-policy/ 

Guidance for Implementing NSPM 33: 

https://www.whitehouse.gov/wpcontent/uploads/2022/01/010422-

NSPM-33-ImplementationGuidance.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%20

Xavier%20Becerra%20

SUBJECT%3A%20Protected

%20Communications 

Foundations for Evidence-Based 

Policymaking Act (‘‘Evidence Act’’): 

https://www.congress.gov/bill/115thcongress/house-bill/4174/text 

Notification and Federal Employee 

Antidiscrimination and Retaliation 

Act (‘‘No FEAR Act’’): https://

www.govinfo.gov/content/pkg/PLAW107publ174/html/PLAW-107

publ174.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/policyregulations/policy/federal-advisorycommittee-management/legislationand-regulations/the-federal-advisorycommittee-act 

Paperwork Reduction Act: https://

www.govinfo.gov/content/pkg/PLAW104publ13/html/PLAW104publ13.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 


ddrumheller on DSK120RN23PROD with NOTICES1
106536 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

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-FederalScientific-Integrity-Policy-and-Practice.pdf. 2Some 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. 3Presidential 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-ingovernment-through-scientific-integrity-andevidence-based-policymaking/. 4Presidential 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-pressoffice/memorandum-heads-executivedepartments-and-agencies-3-9-09. 5Presidential 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. 6A report by the Scientific Integrity FastTrack 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-FederalScientific-Integrity-Policy-and-Practice.pdf. 8Examples may include (1) suppressing a 

decisionmaker’s ability to offer the best 

judgment based on scientific information; (2) 

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. 10See Federal Research Misconduct Policy, 

65 FR 76260, 76262 (Dec. 6, 2000); see also 

https://ori.hhs.gov/definition-researchmisconduct. 11Public Law 112–199 § 110. 12 5 U.S.C. 2302(b)(8). 13See 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. 14HHS 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. 15HHS Grants Policy Administration 

Manual Version 1.02. November 13, 2023. 16 45 CFR 75.372. 17Presidential 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. 18Presidential 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-OSTPPublic-Access-Memo.pdf. 19This 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/EAE37A7DA3C38

BF38525894700775339/$FILE/LA-23-03

%20The%20Standards%20

of%20Conduct%20and%2018%20U.S.C.

%20%C2%A7%20208%20as%20Applied

%20to%20Official%20Social

%20Media%20Use.pdf. 20Memorandum 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/0/195DAE83D38EF6A9852585B

A005BEC69/$FILE/LA-15-03-2.pdf. 21Office 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/finalinformation-quality-bulletin-for-peer-review. 22 5 U.S.C. 7513, 4303. 23Commissioned Corps Directive 111.02. 24Subject 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/scientificintegrity-memo-12172010.pdf. 26See 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.’’ 27https://oig.hhs.gov/fraud/report-fraud/

before-you-submit/. 

Dated: December 16, 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. 2024–30934 Filed 12–27–24; 8:45 a.m.] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Information Technology 

Advisory Committee Schedule of 

Meetings 

AGENCY: Assistant Secretary for 

Technology Policy (ASTP), HHS. 

ACTION: Notice of meetings. 

SUMMARY: The Health Information 

Technology Advisory Committee 

(HITAC) was established in accordance 

with the 21st Century Cures Act and the 

Federal Advisory Committee Act. The 

HITAC, among other things, identifies 

priorities for standards adoption and 

makes recommendations to the 

Assistant Secretary for Technology 

Policy/National Coordinator for Health 

Information Technology. The HITAC 

will hold public meetings throughout 

2025. See list of public meetings below. 

FOR FURTHER INFORMATION CONTACT: Seth 

Pazinski, Designated Federal Officer, at 

Seth.Pazinski@hhs.gov, (202) 384–2246. 

SUPPLEMENTARY INFORMATION: Section 

4003(e) of the 21st Century Cures Act 

(Pub. L. 114–255) establishes the Health 

Information Technology Advisory 


ddrumheller on DSK120RN23PROD with NOTICES1