[Federal Register Volume 81, Number 142 (Monday, July 25, 2016)]
[Notices]
[Pages 48426-48427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17495]


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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:  Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Zhiyu Li, Ph.D., Mount Sinai School of Medicine: Based upon the 
evidence and findings of an investigation report by the Mount Sinai 
School of Medicine (MSSM) and additional analysis conducted by ORI in 
its oversight review, ORI found that Dr. Zhiyu Li, former Postdoctoral 
Fellow, MSSM, engaged in research misconduct in research that was 
supported by National Cancer Institute (NCI), National Institutes of 
Health (NIH), grant R21 CA120017. ORI found that falsified and/or 
fabricated data were included in the following published papers, 
submitted manuscript, poster presentation, and grant applications:

 Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C. ``A 
Genetically Enhanced Anaerobic Bacterium for Oncopathic Therapy of 
Pancreatic Cancer.'' JNCI 100(19):1389-1400, October 2008 (hereafter 
referred to as ``JNCI 2008'') (Retracted 02/2010).
 Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C. 
``The Oncopathic Potency of Clostridium perfringens is Independent of 
its [alpha]-Toxin Gene.'' HGT 20:751-758, July 2009 (hereafter referred 
to as ``HGT 2009'') (Retracted 03/2010).
 Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C. 
``Oncopathic Bacteriotherapy with Engineered C. perfringens Spores is 
Superior and Complementary to Gemcitabine Treatment in an Orthotopic 
Murine Model of Pancreatic Cancer.'' Submitted for publication in Can. 
Res. (hereafter referred to as the ``Can. Res. Manuscript 2009'').
 Li, Z., Fallon, J., Mandeli, J., Wetmur, J., & Woo, S.L.C. 
``Oncopathic Bacteriotherapy with Cp/plc-/sod-/PVL is Complementary to 
Gemcitabine Treatment for Pancreatic Cancer in Mice.'' Presented at the 
12th Annual Meeting of the American Society of Gene Therapy, May 27-30, 
2009.
 R21 CA120017-02
 R21 CA120017 Final Progress Report
 R01 CA130897-01
 R01 CA130897-01 A1
 R01 CA130897-01 A2
 R01 CA130897-01 A2 Supplemental Material
 R01 CA148697-01

    The JNCI 2008 and HGT 2009 papers were retracted, and the Can. Res. 
Manuscript 2009 was withdrawn.
    ORI found that the Respondent intentionally, knowingly, and 
recklessly engaged in research misconduct by falsely claiming to have 
generated recombinant Clostridium perfringens (Cp) strains, Cp/sod-, 
Cp/sod-/PVL, and Cp/plc-/sod-/PVL, to depict the effects of recombinant 
Cp strains on their ability to destroy cancer cells in a murine model, 
when these bacterial strains were not produced nor the data derived 
from them, and by falsifying histopathological data reported in fifty-
seven (57) images in two (2) published papers, one (1) submitted 
manuscript, two (2) poster presentations, and seven (7) of Respondent's 
supervisor's grant applications and fabricating the corresponding 
nineteen (19) summary bar graphs that were based on those false images.
    Specifically, Respondent trimmed and used portions of Figure 6 
(right panel) of a draft R21 CA120017-01 grant application, 
representing an image of liver tumor two (2) days after injection of 
Cp/plc- bacteria, to represent unrelated results from different 
experiments in:

 Figures 5D and 7C (left panel), grant R21 CA120017 Final 
Progress Report
 Figure 6A, grant R01 CA130897-01
 Figures 9D and 17A (top left, middle, and right panels and 
bottom left panel), grant R01 CA130897-01 A1

[[Page 48427]]

 Figures 6D and 9C (left panel), grant R01 CA130897-01 A2
 Figure 2A (left, middle, and right panels) in R01 CA130897-01 
A2 Supplemental Material
 Figures 4D and 7C (left panel), grant R01 CA148697-01
 Figure 4D (left panel), JNCI 2008
 Figure 3A (left panel), HGT 2009
 Figure 1A (left, middle and right panels), Can. Res. 
Manuscript 2009
 Figure labeled ``Intratumoral Bacterial Titers and 
Quantification of Tumor Necrosis'' (top left panel), AGST 2009 Poster 
presentation 2

    Respondent trimmed and used portions of Figure 6C of R21 CA120017-
02, representing pancreatic tumor five (5) days after injection of Cp/
sod- bacteria, to represent results from different experiments in:

 Figures 5E, 6E and 7C (right panel), grant R21 CA120017 Final 
Progress Report
 Figures 9E, 10E, and 13C (right panel), grant R01 CA130897-01 
A1
 Figures 6E, 7E and 9C (right panel), grant R01 CA130897-01 A2
 Figures 4E, 5E and 7C (right panel), grant R01 CA148697-01
 Figure 4D (right panel), JNCI 2008
 Figure 3A (middle and right panels), HGT 2009
 Figure labeled ``Intratumoral Bacterial Titers and 
Quantification of Tumor Necrosis'' (top right and middle panels), AGST 
2009 Poster presentation 2

    Respondent trimmed and used a portion of a figure that was reported 
as mouse pancreatic tumor tissue treated with control liposomes in four 
(4) figures (Figure 6D in R21 CA120017 Final Progress Report, Figure 
10D in R01 CA130897-01 A1, Figure 7D in R01 CA130897-01 A2, and Figure 
5D in R01 CA148697-01), to represent results from mouse pancreatic 
tumor tissue not treated with control liposomes in:

 Figures 7C (middle panel), grant R21 CA120017 Final Progress 
Report
 Figure 13C (left panel), grant R01 CA130897-01 A1
 Figures 9C (middle panel), grant R01 CA130897-01 A2
 Figure 7C (middle panel), grant R01 CA148697-01
 Figure 4D (middle panel), JNCI 2008
 Figure entitled ``Oncopathic Potency of Cp/sod-/PVL in Tumor-
bearing Mice'' row C (left panel), AGST 2009 Poster presentation 1

    Respondent falsified at least four (4) and possibly eight (8) 
images by using and relabeling Figures 4A (left panel), 4B (right 
panel), and 4B (left panel) in JNCI 2008 and Figure 1B (center panel) 
of Cancer Res. Manuscript 2009, to represent different experimental 
conditions in Figures 3C (middle panel), 3B (left panel), 3C (right 
panel), and 3D (left panel) in HGT 2009 respectively.
    Respondent trimmed and used portions of Figure 4E (right panel) in 
JNCI 2008, representing pancreatic tumor from mice injected with Cp/
sod-/PVL bacteria, to represent mice injected with Cp/plc-/sod-/PVL 
bacteria in the following:

 Figure 2, row B (right panel), R01 CA130897 01 A2 Supplemental 
Material
 Figure 3, row D (right panel), HGT 2009
 Figure entitled ``Intratumoral bacterial Titers and 
Quantification of Tumor Necrosis'' (bottom right panel), AGST 2009 
Poster presentation 2
 Figure 1, row B (right panel), Can. Res. Manuscript 2009

    The Respondent also fabricated the resulting quantitative data in 
nineteen (19) summary bar-graphs based on the false histopathological 
images in:

 Figure 7C, grant R21 CA120017 Final Progress Report
 Figures 13C and 17B, grant R01 CA130897-01 A1
 Figure 9C, grant R01 CA130897-01 A2
 Figure 2A-B, grant R01 CA130897-01 A2 Supplemental Material
 Figure 7C, grant R01 CA148697-01
 Figures 4A, B, D, and E, JNCI 2008
 Figures 3A-D, HGT 2009
 Figure 1C, Can. Res. Manuscript 2009
 Figure entitled ``Oncopathic Potency of Cp/sod-/PVL in Tumor-
bearing Mice'' graph (C) in AGST 2009 Poster presentation 1
 Figure entitled ``Intratumoral Bacterial Titers and 
Quantification of Tumor Necrosis'' top and bottom row graphs in AGST 
2009 Poster presentation 2

The following administrative actions have been implemented for a period 
of five (5) years, beginning on July 3, 2016:
    (1) Respondent is debarred from any contracting or subcontracting 
with any agency of the United States Government and from eligibility 
for, or involvement in, nonprocurement programs of the United States 
Government referred to as ``covered transactions'' pursuant to HHS' 
Implementation (2 CFR part 376 et seq) of Office of Management and 
Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and 
Suspension, 2 CFR part 180 (collectively the ``Debarment 
Regulations''); and
    (2) Respondent is prohibited from serving in any advisory capacity 
to the U.S. Public Health Service (PHS) including, but not limited to, 
service on any PHS advisory committee, board, and/or peer review 
committee, or as a consultant.

FOR FURTHER INFORMATION CONTACT: Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8800.

Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2016-17495 Filed 7-22-16; 8:45 am]
 BILLING CODE 4150-31-P