[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Notices]
[Pages 38632-38633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15887]


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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:
    Mona Thiruchelvam, Ph.D., University of Medicine and Dentistry of 
New Jersey: Based on the report of an investigation conducted by the 
University of Medicine and Dentistry of New Jersey (UMDNJ) and 
additional analysis conducted by ORI in its oversight review, ORI found 
that Dr. Mona Thiruchelvam, former Assistant Professor, Department of 
Environment and Occupational Health Science Institute (EOHSI), UMDNJ, 
engaged in research misconduct in research supported by National 
Institute of Environmental Health Sciences (NIEHS), National Institutes 
of Health (NIH), grants P30 ES05022, P30 ES01247, and R01 ES10791 and 
the intramural program at the National Institute on Drug Abuse (NIDA), 
NIH.
    ORI found that the Respondent engaged in research misconduct by 
falsifying and fabricating cell count data that she claimed to have 
obtained through stereological methods in order to falsely report the 
effects of combined exposure of the pesticides paraquat and maneb on 
dopaminergic neuronal death and a neuroprotective role for estrogen in 
a murine model of Parkinson's disease. The Respondent provided to the 
institution corrupted data files as the data for stereological cell 
counts of nigrostriatal neurons in brains of several mice and rats by 
copying a single data file from a previous experiment and renaming the 
copies to fit the description of 13 new experiments composed of 293 
data files when

[[Page 38633]]

stereological data collection was never performed for the questioned 
research.
    The fabricated data, falsified methodology, and false claims based 
on fabricated and falsified data were reported in two NIEHS, NIH, grant 
applications, two publications, a poster, and a manuscript in 
preparation:
     R01 ES016277, ``Development Pesticide Exposure: The 
Parkinson's Disease Phenotype'' (Dr. Mona J. Thiruchelvam, Principal 
Investigator [P.I.]), submitted 1/26/2007 and funded.
     R01 ES015041, ``Gender and the Parkinson's Disease 
Phenotype'' (Dr. Mona J. Thiruchelvam, P.I.), submitted 12/19/05.
     Rodriguez, V.M., Thiruchelvam, M., & Cory-Slechta, D.A. 
``Sustained Exposure to the Widely Used Herbicide, Atrazine: Altered 
Function and Loss of Neurons in Brain Monamine Systems.'' Environ 
Health Perspect. 113(6):708-715, 2005 (``EHP paper'').
     Thiruchelvam, M., Prokopenko, O., Cory-Slechta, D.A., 
Richfield, E.K., Buckley, B., & Mirochnitchenko, O. ``Overexpression of 
Superoxide Dismutase or Glutathione Peroxidase Protects against the 
Paraquat + Maneb-induced Parkinson Disease Phenotype.'' J. Biol. Chem. 
280(23):22530-22539, 2005 (``JBC paper'').
     Harvey, K., Victor, A.I., Wang, Y., Kochar, Y., Cory-
Slechta, D.A., & Thiruchelvam, M. ``Gene Delivery of GDNF Impedes 
Progressive Neurodegeneration in Paraquat and Maneb Exposure Model of 
Parkinson's Disease.'' Poster presentation, Neuroscience 2006 
(``Neuroscience poster'').
     Thiruchelvam, M., Kochar, Y., Mehta, H., Prokopenko, O., 
Cory-Slechta, D.A., Richfield, E.K., & Mirochnitchenko, O. ``Mechanisms 
associated with gender difference in the paraquat and maneb animal 
model of Parkinson's disease, 2006 (``manuscript'').
    Specifically, ORI finds that the Respondent engaged in research 
misconduct by knowingly and intentionally:
     Falsifying and fabricating summary bar graphs and 
methodology for stereological cell counts in a murine model of 
Parkinson's disease, when the stereological counts were never 
performed;
     Copying and altering in multiple ways a single stereology 
``.dat'' computer file generated on August 18, 2002, and renaming it to 
generate 293 data files representing counts for 13 new experiments that 
were never performed, by altering the files to make them unreadable and 
claiming that these files were from valid stereological cell count 
experiments carried out at UMDNJ between 2004 and 2006;
     Falsifying a bar graph representing brain proteasomal 
activity, by selectively altering data for relative fluorescent unit 
(RFU) values to support the hypothesis that development of Parkinson's 
disease entails proteasomal dysfunction with a higher effect in males 
compared to females;
     By failing to perform stereological cell counts, the 
following figures of summary bar graphs, reported methodology, and 
related claims of the Respondent's JBC paper, EHP paper, a manuscript, 
a poster, and two grant applications were falsified:

--Figure 7B and the related text in R01 ES016277-01 and the 
Neuroscience 2006 poster
--Figure 4 and the related text in R01 ES016277-01
--Figure 9 and the related text in R01 ES016277-01 and R01 ES015041
--Figure 3 and the related text in the JBC paper
--Figure 4 and the related text in the EHP paper
--Figure 5 and the related text in a manuscript in preparation

     By falsifying and selectively altering experimental data 
for relative fluorescent unit values of brain proteasomal activity, the 
summary bar graph in Figure 6 and the claim that combined exposure of 
the pesticides causes significant decreases in proteasomal activity 
with a higher effect in males than in females were falsified in NIH 
grant application R01 ES016277.
    Dr. Thiruchelvam has entered into a Voluntary Exclusion Agreement 
(Agreement) and has voluntarily agreed for a period of seven (7) years, 
beginning on June 13, 2012:
    (1) To exclude herself from any contracting or subcontracting with 
any agency of the United States Government and from eligibility 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 OMB Guidelines to Agencies on Governmentwide 
Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment 
Regulations'');
    (2) To exclude herself 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; and
    (3) to request retraction of the following two papers:
     Environ Health Perspect. 113(6):708-715, 2005
     J. Biol. Chem. 280(23):22530-22539, 2005.

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

John Dahlberg,
Director, Division of Investigative Oversight, Office of Research 
Integrity.
[FR Doc. 2012-15887 Filed 6-27-12; 8:45 am]
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