[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Notices]
[Pages 28643-28645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10253]


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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 Dr. 
Shin-Hee Kim (Respondent), who was an Assistant Professor of Veterinary 
Medicine, University of Maryland (UMD). Dr. Kim engaged in research 
misconduct in research supported by U.S. Public Health Service (PHS) 
funds, specifically National Institute of Allergy and Infectious 
Diseases (NIAID), National Institutes of Health (NIH), grants R21 
AI100195 and ZIA AI000938 and contract N01 AO60009. The administrative 
actions, including supervision for a period of three (3) years, were 
implemented beginning on March 27, 2020, and are detailed below.

FOR FURTHER INFORMATION CONTACT: Elisabeth A. Handley, 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:
    Dr. Shin-Hee Kim, University of Maryland: Based on an investigation 
conducted by UMD and additional analysis conducted by ORI in its 
oversight review, ORI found that Dr. Shin-Hee Kim, former Assistant 
Professor of Veterinary Medicine, UMD, engaged in research misconduct 
in research supported by PHS funds, specifically NIAID, NIH, grants R21 
AI100195 and ZIA AI000938 and contract N01 AO60009.
    ORI found that Respondent engaged in research misconduct by 
intentionally, knowingly, and/or recklessly falsifying and/or 
fabricating data by altering, reusing, and relabeling same source 
Western blot images, microscopy fields, and data of viral titers and 
mouse immune response from non-correlated experiments to represent the 
results of different viral strains in the following seven (7) published 
papers and two (2) grant applications submitted to NIAID, NIH:
     Mutations in the fusion protein cleavage site of avian 
paramyxovirus serotype 4 confer increased replication and syncytium 
formation in vitro but not increased replication and pathogenicity in 
chickens and ducks. PLoS One 2013;8(1):e50598 (hereafter referred to as 
``PLoS One 2013A'').
     Newcastle disease virus fusion protein is the major 
contributor to protective immunity of genotype-matched vaccine. PLoS 
One 2013;8(8):e74022 (hereafter referred to as ``PLoS One 2013B'').
     Role of C596 in the C-terminal extension of the 
haemagglutinin-neuraminidase protein in replication and pathogenicity 
of a highly virulent Indonesian strain of Newcastle disease virus. J 
Gen Virol. 2014;95(Pt 2):331-6

[[Page 28644]]

(hereafter referred to as ``J Gen Virol. 2014'').
     Newcastle disease virus vector producing human norovirus-
like particles induces serum, cellular, and mucosal immune responses in 
mice. J Virol. 2014;88(17):9718-27 (hereafter referred to as ``J Virol. 
2014'').
     Modified Newcastle disease virus vectors expressing the H5 
hemagglutinin induce enhanced protection against highly pathogenic H5N1 
avian influenza virus in chickens. Vaccine 2014;32(35):4428-35 
(hereafter referred to as ``Vaccine 2014'').
     Immunogenicity of Newcastle disease virus vectors 
expressing Norwalk virus capsid protein in the presence or absence of 
VP2 protein. Virology 2015;484:163-9 (hereafter referred to as 
``Virology 2015'').
     LaSota fusion (F) cleavage motif-mediated fusion activity 
is affected by other regions of the F protein from different genotype 
Newcastle disease virus in a chimeric virus: Implication for virulence 
attenuation. J Gen Virol. 2016;97(6):1297-1303 (hereafter referred to 
as ``J Gen Virol. 2016'').
     R01 AI118879-01, ``Avian paramyxovirus vectored vaccines 
for Norovirus infection,'' submitted to NIAID, NIH, on October 3, 2014.
     R01 AI118879-01A1, ``Avian paramyxovirus vectored vaccines 
for Norovirus infection,'' submitted to NIAID, NIH, on November 5, 
2015.
    Specifically, ORI finds that Respondent knowingly, intentionally, 
and/or recklessly falsified and/or fabricated:
     Western blot images in four (4) figures of three (3) 
published papers by reusing and relabeling images from non-correlated 
blots and using blank backgrounds as blot images with negative 
expression of proteins. Specifically:

--The blot that was used for Figure 3A, first blot of the second band, 
in Vaccine 2014, representing the negative expression of HA0 
protein of the rLaSota virus in DF1 cells after 24 hour infection at 
Multiplicity of Infection (MOI) of 1, was fabricated by using the blank 
background from an uncorrelated original film
--the six (6) blots that were used for Figure 3A, bottom band, in 
Vaccine 2014, representing the expression of Newcastle Disease Virus 
(NDV) haemagglutinin-neuraminidase (HN) proteins in DF1 cells after 24 
hour infection with six modified rNDV virus strains at MOI of 1, also 
were used in Figure 1B, bottom band, in J Gen Virol. 2014 to represent 
the expression of HN proteins of six different virus strains evaluated 
in infected DF1 cells at MOI of 0.1 in the presence of trypsin
--the four (4) blots that were used for Figure 1B, upper band, in J 
Virol. 2014, Figure 1B in grant application R01 AI118879-01, and Figure 
1A in grant application R01 AI118879-01A1, representing the expression 
of VP1 proteins of four modified NDV strains in DF1 cells after 24 hour 
infection at MOI of 1, were fabricated by using blots from an 
uncorrelated film: The first two blots were from the blank background 
and the last two blots were from samples labeled with a different viral 
name--BC/NV101
--the four (4) blots that were used for Figure 3A, third band, in J 
Virol. 2014, representing the VP1 protein expression of the modified 
rNDV virus strain in DF1 cells at four time points, were fabricated by 
using four blots labeled with a different viral name (BC/NV101) from 
the same uncorrelated film of the last hyphen bullet

     nine (9) microscopy fields presented in four (4) figures 
of four (4) published papers by reusing and relabeling same source 
images to representing different results. Specifically:

--The microscope field that was used for Figure 1B in J Gen Virol. 
2016, representing the cytopathic effect of rLaSota virus infection 
with allantoic fluid in DF1 cells, also was used in Figure 1B in J Gen 
Virol. 2016 to represent the cytopathic effect of rBC/AKO-F virus 
infection with allantoic fluid in DF1 cells
--the microscope field that was used for Figure 1B in J Gen Virol. 
2016, representing the cytopathic effect of rBC/Las-Fc-AKO-F virus 
infection without allantoic fluid in DF1 cells, also was used in a 
PowerPoint presentation on Respondent's laptop to represent the 
cytopathic effect of rBan 010 Las Fc virus and rBan 010 Las Fc/D403N 
virus
--the microscope field that was used for Figure 1B in J Gen Virol. 
2016, representing the cytopathic effect of rLaSota virus infection 
without allantoic fluid in DF1 cells, also was used in a PowerPoint 
presentation on Respondent's laptop to represent the cytopathic effect 
of rAPMV-2/BC F virus
--the microscope field that was used for Figure 1B in J Gen Virol. 
2016, representing the cytopathic effect of rBC/Las-Fc virus infection 
without allantoic fluid in DF1 cells, also was used in a PowerPoint 
presentation on Respondent's laptop to represent the cytopathic effect 
of mock infected sample
--the two images that were used for Figure 2B in Virology 2015, 
representing rLaSota-NV (the middle one) and rBCm-NV (the right one) 
expressed VLP in allantoic fluid of chicken eggs, were fabricated by 
splitting a microscopy field into two parts
--the image that was used for Figure 3A in PLoS One 2013A, representing 
a mock control in the experiment in which DF1 cells were infected by a 
group of viruses at MOI of 0.1 for 72 hours, also was used in Figure 2A 
of PLoS One 2013B to represent a mock control in a different experiment 
in which DF1 cells were infected by a different group of viruses at MOI 
of 0.01 for 72 hours
     data of viral titers and mouse immune responses to viral 
immunization presented in five (5) figures of one (1) published paper 
by altering, reusing, and relabeling data from non-correlated 
experiments or by fabricating data that did not exist. Specifically:

--The data that were used for Figure 2 in J Virol. 2014, representing 
titers of four virus strains, also were used to represent titers of 
another group of four different virus strains in Respondent's research 
records
--the data that were used for Figures 5, 6, 7, and 8 in J Virol. 2014, 
representing the results of mouse immune responses to the immunization 
of rLaSota-VP1, Modified rNDV-VP1, and VLP viruses, also were used to 
represent the results of mouse responses to the immunization of 
different virus strains in Respondent's research records
--the data that were used for Figures 5, 6, 7, and 8 in J Virol. 2014, 
representing the results of mouse immune responses to PBS injection as 
negative controls, were fabricated as the data did not exist

    Dr. Kim entered into an Agreement and agreed to the following:
    (1) Respondent agreed to have her research supervised for a period 
of three (3) years beginning on March 27, 2020. Respondent agreed that 
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 on PHS-supported 
research, Respondent shall ensure that a plan for supervision of 
Respondent's duties is submitted to ORI for approval. The supervision 
plan must be designed to ensure the scientific integrity of

[[Page 28645]]

Respondent's research contribution. Respondent agreed that she shall 
not participate in any PHS-supported research until such a supervision 
plan is submitted to and approved by ORI. Respondent agreed to maintain 
responsibility for compliance 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 three (3) 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 any PHS grant 
applications (including supplements, resubmissions, etc.), manuscripts 
reporting PHS-funded research submitted for publication, and abstracts. 
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/publication is 
supported by the research record.
    (3) Respondent agreed that for a period of three (3) years 
beginning on March 27, 2020, any institution employing her shall 
submit, in conjunction with each application of PHS funds, or report, 
manuscript, or abstract involving PHS-supported research in which 
Respondent is involved, a certification to ORI that the data provided 
by Respondent are based on actual experiments or are otherwise 
legitimately derived and that the data, procedures, and methodology are 
accurately reported in the application, report, manuscript, or 
abstract.
    (4) If no supervisory plan is provided to ORI, Respondent agreed to 
provide certification to ORI at the conclusion of the supervision 
period that she has not engaged in, applied for, or had her name 
included on any application, proposal, or other request for PHS funds 
without prior notification to ORI.
    (5) Respondent agreed to exclude herself voluntarily from serving 
in any advisory capacity to PHS including, but not limited to, service 
on any PHS advisory committee, board, and/or peer review committee, or 
as a consultant for a period of three (3) years, beginning on March 27, 
2020.
    (6) As a condition of the Agreement, Respondent will request that 
the following papers be corrected or retracted in accordance with 42 
CFR 93.407(a)(1):

 PLoS One 2013;8(1):e50598
 PLoS One 2013;8(8):e74022
 J Gen Virol. 2014;95(Pt 2):331-6
 J Virol. 2014;88(17):9718-27
 Vaccine 2014;32(35):4428-35
 Virology 2015;484:163-9
 J Gen Virol. 2016;97(6):1297-1303

Respondent will copy ORI and the Research Integrity Officer at UMD on 
the correspondence.

    Dated: May 8, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2020-10253 Filed 5-12-20; 8:45 am]
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