[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Notices]
[Pages 73035-73037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23464]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Findings of research misconduct have been made against Lara S. 
Hwa, Ph.D. (Respondent), who is an Assistant Professor, Department of 
Psychology and Neuroscience, Baylor University (BU), and formerly was a 
Postdoctoral Fellow, School of Medicine, University of North Carolina 
at Chapel Hill (UNC-CH). Respondent engaged in research misconduct in 
research supported by U.S. Public Health Service (PHS) funds, 
specifically National Institute on Alcohol Abuse and Alcoholism 
(NIAAA), National Institutes of Health (NIH), grants K99/R00 AA027576, 
T32 AA007573, F31 AA027129, F32 AA026485, R01 AA019454, U01 AA020911, 
R01 AA025582, and P60 AA011605 and included in two grant applications 
submitted for PHS funds, specifically K99 AA027576 submitted to NIAAA, 
NIH, and R01 DK136486 submitted to

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the National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), NIH. The administrative actions, including supervision for a 
period of four (4) years, were implemented beginning on August 24, 
2023, and are detailed below.

FOR FURTHER INFORMATION CONTACT: Sheila Garrity, JD, MPH, MBA, 
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 
240, Rockville, MD 20852, (240) 453-8200.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of 
Research Integrity (ORI) has taken final action in the following case:
    Lara S. Hwa, Ph.D., Baylor University and University of North 
Carolina at Chapel Hill: Based on the report of an investigation 
conducted by BU and UNC-CH and additional analysis conducted by ORI in 
its oversight review, ORI found that Lara S. Hwa, Ph.D., who is an 
Assistant Professor, Department of Psychology and Neuroscience, BU, and 
formerly was a Postdoctoral Fellow, School of Medicine, UNC-CH, engaged 
in research misconduct in research supported by PHS funds, specifically 
NIAAA, NIH, grants K99/R00 AA027576, T32 AA007573, F31 AA027129, F32 
AA026485, R01 AA019454, U01 AA020911, R01 AA025582, and P60 AA011605 
and included in two grant applications submitted for PHS funds, 
specifically K99 AA027576 submitted to NIAAA, NIH, and R01 DK136486 
submitted to NIDDK, NIH.
    ORI found that Respondent engaged in research misconduct by 
knowingly or recklessly falsifying and/or fabricating data, methods, 
results, and conclusions in animal models of alcohol use disorders. 
Specifically, Respondent falsified and/or fabricated experimental 
timelines, group conditions, sex of animal subjects, mouse strains, and 
behavioral response data in the following two (2) published papers and 
two (2) PHS grant applications:
    <bullet> Alcohol Drinking Alters Stress Response to Predator Odor 
via BNST Kappa Opioid Receptor Signaling in Male Mice. Elife. 2020 Jul 
21;9:e59709. doi: 10.7554/eLife.59709 (hereafter referred to as ``Elife 
2020''). Retraction in: Elife. 2021 Nov 2;10:e74986. doi: 10.7554/
eLife.74986.
    <bullet> Predator Odor Increases Avoidance and Glutamatergic 
Synaptic Transmission in the Prelimbic Cortex via Corticotropin-
releasing Factor Receptor 1 Signaling. Neuropyschopharmacology. 2019 
Mar;44(4):766-775. doi: 10.1038/s41386-018-0279-2 (hereafter referred 
to as ``Neuropyschopharmacology 2019'').
    <bullet> K99/R00 AA027576, ``Long-term Alcohol Drinking Alters 
Stress Engagement of BNST Circuit Elements,'' submitted to NIAAA, NIH, 
Funding Period: September 20, 2019-August 31, 2024.
    <bullet> R01 DK136486, ``Neuropeptide Characterization of Limited 
Access Sugar Drinking in Mice,'' submitted to NIDDK, NIH, 
administratively withdrawn on December 9, 2022.
    Specifically, ORI finds that Respondent knowingly or recklessly:

<bullet> Falsified blood ethanol (alcohol) concentration results by 
using female dynorphin mice from an unrelated study to represent 
ethanol concentrations in male wildtype mice in Figure 1D of Elife 2020
<bullet> Falsified ethanol drinking ranges by including mice that drank 
outside of the range reported in Figures 2C, 4, and 6 of Elife 2020 and 
Figure 4 of K99 AA027576
<bullet> Falsified ethanol withdrawal times by including mice 
undergoing a broad range of withdrawal durations but reporting 
different withdrawal parameters in Figures 2C, 4, 6, and Figure 6-
figure supplement 1 of Elife 2020 and Figure 4 of K99 AA027576
<bullet> Falsified and/or fabricated mouse behavioral data by 
selectively switching, omitting, or altering raw data by:
    --Switching mouse location data from tracking software for water 
and ethanol treatment groups in Figures 1F, 1G, and 1H of Elife 2020
    --Reporting unrelated heatmap images of mouse spatial location from 
a separate previous study to falsely demonstrate representative heatmap 
images for experimental conditions reported in Figure 1F of Elife 2020
    --Falsifying or fabricating mouse location data for 2,4,5, 
trimethyl-3-thiazoline (TMT) (i.e., predator odorant) contact values in 
Figures 1G, 3E, and 5I of Elife 2020
<bullet> Falsified immunolabeling results for c-Fos positive nuclei 
values by selectively switching or omitting raw data reported in mouse 
prelimbic and infralimbic subregions in mice previously exposed to H2O 
(control), vanilla (novel odorant), or TMT in Figures 2b, 2c, and 2d of 
Neuropsychopharmacology 2019
<bullet> Falsified sample size by duplicating four (4) data points to 
falsely report spontaneous excitatory post-synaptic current (sEPSC) 
frequency datapoints of electrophysiological recordings of eight (8) 
animal subjects in the water and NBI27914 treatment group in Figure 5f 
of Neuropyschopharmacology 2019 and Figure 6 of R01 DK136486

    Respondent entered into a Voluntary Settlement Agreement 
(Agreement) and voluntarily agreed to the following:
    (1) Respondent will have her research supervised for a period of 
four (4) years beginning on August 24, 2023 (the ``Supervision 
Period''). Prior to the submission of an application for PHS support 
for a research project on which Respondent's participation is proposed 
and prior to Respondent's participation in any capacity in PHS-
supported research, Respondent will submit a plan for supervision of 
Respondent's duties to ORI for approval. The supervision plan must be 
designed to ensure the integrity of Respondent's research. Respondent 
will not participate in any PHS-supported research until such a 
supervision plan is approved by ORI. Respondent will comply with the 
agreed-upon supervision plan.
    (2) The requirements for Respondent's supervision plan are as 
follows:
    i. A committee of 2-3 senior faculty members at the institution who 
are familiar with Respondent's field of research, but not including 
Respondent's supervisor or collaborators, will provide oversight and 
guidance for a period of four (4) years from the effective date of the 
Agreement. The committee will review primary data from Respondent's 
laboratory on a quarterly basis and submit a report to ORI at six (6) 
month intervals setting forth the committee meeting dates and 
Respondent's compliance with appropriate research standards and 
confirming the integrity of Respondent's research.
    ii. The committee will conduct an advance review of each 
application for PHS funds, or report, manuscript, or abstract involving 
PHS-supported research in which Respondent is involved. The review will 
include a discussion with Respondent of the primary data represented in 
those documents and will include a certification to ORI that the data 
presented in the proposed application, report, manuscript, or abstract 
are supported by the research record.
    (3) During the Supervision Period, Respondent will ensure that any 
institution employing her submits, in conjunction with each application 
for PHS funds, or report, manuscript, or abstract involving PHS-
supported research in which Respondent is involved, a certification to 
ORI that the

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data provided by Respondent are based on actual experiments or are 
otherwise legitimately derived and that the data, procedures, and 
methodology are accurately reported and not plagiarized in the 
application, report, manuscript, or abstract.
    (4) If no supervision plan is provided to ORI, Respondent will 
provide certification to ORI at the conclusion of the Supervision 
Period that her participation was not proposed on a research project 
for which an application for PHS support was submitted and that she has 
not participated in any capacity in PHS-supported research.
    (5) During the Supervision Period, Respondent will exclude herself 
voluntarily from serving in any advisory or consultant capacity to PHS 
including, but not limited to, service on any PHS advisory committee, 
board, and/or peer review committee.
    (6) Respondent will request that the following paper be corrected 
or retracted:
    <bullet> Neuropyschopharmacology. 2019 Mar;44(4):766-775. doi: 
10.1038/s41386-018-0279-2. Respondent will copy ORI and the Research 
Integrity Officer at UNC-CH on the correspondence with the journal.

    Dated: October 19, 2023.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2023-23464 Filed 10-23-23; 8:45 am]
BILLING CODE 4150-31-P