[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77128-77129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27316]


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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 Alice 
C. Chang, Ph.D. (formerly named Chun-Ju Chang) (Respondent), who was an 
Associate Professor of Basic Medical Sciences, College of Veterinary 
Medicine, Purdue University (PU). Respondent engaged in research 
misconduct in research supported by U.S. Public Health Service (PHS) 
funds, specifically National Cancer Institute (NCI), National 
Institutes of Health (NIH), grants P30 CA023168 and R37 CA215087. The 
administrative actions, including debarment for a period of ten (10) 
years, were implemented beginning on December 7, 2022, and are detailed 
below.

FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting 
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:
    Alice C. Chang, Ph.D., Purdue University: Based on the report of an 
investigation conducted by PU and additional analysis conducted by ORI 
in its oversight review, ORI found that Dr. Alice C. Chang (formerly 
named Chun-Ju Chang), former Associate Professor of Basic Medical 
Sciences, College of Veterinary Medicine, PU, engaged in research 
misconduct in research supported by U.S. Public Health Service (PHS) 
funds, specifically National Cancer Institute (NCI), National 
Institutes of Health (NIH), grants P30 CA023168 and R37 CA215087.
    ORI found that Respondent engaged in research misconduct by 
knowingly, intentionally, or recklessly falsifying and/or fabricating 
data included in the following sixteen (16) grant applications 
submitted for PHS funds:
     R21 CA191797-01, ``Targeting miR-200c for early detection 
of aggressive breast cancer,'' submitted to NCI, NIH, on 02/17/2014.
     R21 CA194474-01, ``The role of miRNA regulated-cell 
polarity machinery in breast cancer stem cell fate decision,'' 
submitted to NCI, NIH, on 06/19/2014.
     R03 CA198606-01, ``Targeting cell polarity machinery to 
exhaust breast cancer stem cell pool,'' submitted to NCI, NIH, on 10/
28/2014 (funded).
     R01 CA205940-01, ``Epigenetic regulation governing ATRA-
mediated cellular programming,'' submitted to NCI, NIH, on 06/04/2015.
     R01 CA208325-01, ``Epigenetic mechanism underlying 
retinoic acid resistance in breast cancer stem cells,'' submitted to 
NCI, NIH, on 10/05/2015.
     R01 CA208325-01A1, ``Epigenetic mechanism underlying 
retinoic acid resistance in tumor stem cells,'' submitted to NCI, NIH, 
on 11/07/2016.
     R21 CA215908-01, ``Targeting EMT-induced mitochondrial 
heterogeneity in breast cancer,'' submitted to NCI, NIH, on 06/24/2016.
     R01 CA211063-01, ``The role of mitochondrial regulation in 
directing the cancer stem cell fate,'' submitted to NCI, NIH, on 01/28/
2016.
     R01 CA215087-01, ``Targeting metformin-directed stem cell 
fate in triple negative breast cancer,'' submitted to NCI, NIH, on 06/
03/2016.
     R37 CA215087-01A1, ``Targeting metformin-directed stem 
cell fate in triple negative breast cancer,'' submitted to NCI, NIH, on 
03/06/2017 (funded).
     R01 CA226951-01, ``(PQ11) Role of DHA in directing luminal 
differentiation and therapy response in triple-negative breast 
cancer,'' submitted to NCI, NIH, on 06/22/2017.
     R01 CA231940-01, ``Regulation of Tet2 in programming 
mammary stem cell fate,'' submitted to NCI, NIH, on 10/05/2017.

[[Page 77129]]

     R01 CA231940-01A1, ``Regulation of Tet2 in programming 
mammary stem cell fate,'' submitted to NCI, NIH, on 06/26/2018.
     R01 CA233941-01, ``DHA directs epigenetic programming in 
triple-negative breast cancer,'' submitted to NCI, NIH, on 02/05/2018.
     R01 GM121775-01, ``The role of Tet2 regulation in 
directing mammary stem cell fate,'' submitted to the National Institute 
of General Medical Sciences (NIGMS), NIH, on 02/05/2016.
     R35 GM124972-01, ``Novel role of microRNA in directing 
stem cell fate decision,'' submitted to NIGMS, NIH, on 11/04/2016.
    Specifically, ORI found that Respondent knowingly, intentionally, 
or recklessly falsified and/or fabricated data from the same mouse 
models or cell lines by reusing the data, with or without manipulation, 
to represent unrelated experiments from different mouse models or cell 
lines with different treatments in three hundred eighty-four (384) 
figure panels in sixteen (16) grant applications.
    In addition, ORI found that Respondent engaged in research 
misconduct by knowingly, intentionally, or recklessly falsifying and/or 
fabricating data included in two (2) PHS-supported published papers. 
Respondent neither admits nor denies ORI's findings with respect to the 
two (2) published papers:
     Chang CC, Wu MJ, Yang JY, Camarillo IG, Chang CJ. Leptin-
STAT3-G9a signaling promotes obesity-mediated breast cancer 
progression. Cancer Res. 2015 Jun 1;75(11):2375-86. doi: 10.1158/0008-
5472.CAN-14-3076.
     Wu MJ, Kim MR, Chen YS, Yang JY, Chang CJ. Retinoic acid 
directs breast cancer cell state changes through regulation of TET2-
PKC[zeta] pathway. Oncogene 2017 Jun 1;36(22):3193-206. doi: 10.1038/
onc.2016.467.
    Specifically, ORI found that Respondent intentionally, knowingly, 
or recklessly falsified and/or fabricated:
     confocal image data for generation, differentiation, and 
drug sensitivity of cancer stem cells (CSC) in mouse models and cell 
lines by reusing the data, with or without manipulation, and relabeling 
them to represent different experiments in fifty-four (54) figure 
panels included in fifteen (15) grant applications;
     Western blot and co-IP blot images for different protein 
expression in different mouse models and cell lines by reusing the 
images, with or without manipulation, and relabeling them to represent 
different experiments in eighty-one (81) figure panels in thirteen (13) 
grant applications;
     figures, charts, and graphs reporting gene expression 
related results for the global or tissue-related gene expression in 
mouse models and cell lines with drug treatments by reusing them, with 
or without manipulation, and relabeling them to represent different 
experiments in one hundred nineteen (119) figure panels in fifteen (15) 
grant applications and two (2) published papers;
     figures, charts, and graphs about cellular experiment 
related results for different mouse models and cell lines by reusing 
them, with or without manipulation, and relabeling them to represent 
different experiments in forty-two (42) figure panels in thirteen (13) 
grant applications;
     photomicrographs for different results from different 
mouse models and cell lines by reusing them, with or without 
manipulation, and relabeling them to represent different experiments in 
eighty-five (85) figure panels in fifteen (15) grant applications;
     CSC frequency (xenograft tumor formation) data reporting 
different results from either mouse models or cell lines by reusing and 
relabeling the same data to represent different experiments in three 
(3) figure panels in three (3) grant applications.
    Dr. Chang entered into a Voluntary Exclusion Agreement (Agreement) 
and voluntarily agreed to the following:
    (1) Respondent will exclude herself voluntarily for a period of ten 
(10) years beginning on December 7, 2022 (the ``Exclusion Period'') 
from any contracting or subcontracting with any agency of the United 
States Government and from eligibility for or involvement in 
nonprocurement or procurement transactions referred to as ``covered 
transactions'' in 2 CFR parts 180 and 376 (collectively the ``Debarment 
Regulations'').
    (2) During the Exclusion 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.
    (3) Respondent will request that the following papers be corrected:
     Cancer Res. 2015 Jun 1; 75(11):2375-86.
     Oncogene 2017 Jun 1; 36(22):3193-206.
    Respondent will copy ORI and the Research Integrity Officer at PU 
on the correspondence with the journal(s).

    Dated: December 13, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2022-27316 Filed 12-15-22; 8:45 am]
BILLING CODE 4150-31-P