Findings of Research Misconduct, 38632-38633 [2012-15887]
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Federal Register / Vol. 77, No. 125 / Thursday, June 28, 2012 / Notices
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ADDRESSES: Individuals, groups, and
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for the Study of Bioethical Issues, 1425
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Washington, DC 20005.
FOR FURTHER INFORMATION CONTACT:
Hillary Wicai Viers, Communications
Director, Presidential Commission for
the Study of Bioethical Issues.
Telephone: 202–233–3960. Email:
hillary.viers@bioethics.gov. Additional
information may be obtained at https://
www.bioethics.gov.
SUPPLEMENTARY INFORMATION: On
November 24, 2009, the President
established the Presidential Commission
for the Study of Bioethical Issues (the
Commission) to advise him on
bioethical issues generated by novel and
emerging research in biomedicine and
related areas of science and technology.
The Commission is charged to identify
and promote policies and practices that
ensure ethically responsible conduct of
scientific research and healthcare
delivery. Undertaking these duties, the
Commission seeks to identify and
examine specific bioethical, legal, and
social issues related to potential
scientific and technological advances;
examine diverse perspectives and
possibilities for international
collaboration on these issues; and
recommend legal, regulatory, or policy
actions as appropriate.
On January 6, 2012, HHS Secretary
Kathleen Sebelius asked the
Commission to ‘‘conduct a thorough
review of the ethical considerations of
conducting clinical trials of medical
countermeasures in children,’’
including the ethical considerations of
conducting a pre- and post-event
pediatric study of Anthrax Vaccine
Adsorbed (AVA) as a component of
post-exposure prophylaxis, in order to
address ‘‘how best to obtain clinical
data on medical countermeasures in
children.’’ Accordingly, the Commission
is examining ethical issues surrounding
the development of medical treatments
to keep children safe in the event of a
public health emergency. While
significant progress has been made in
the development of medical
countermeasures for adults, the
development of similar products for
children has lagged, in part because of
challenges in conducting safety and
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immunogenicity studies. In the 2011
report, ‘‘Challenges in the Use of
Anthrax Vaccine Adsorbed (AVA) in the
Pediatric Population as a Component of
Post-Exposure Prophylaxis,’’ the
National Biodefense Science Board
recommended that the Department of
Health and Human Services move
forward with testing AVA before a
public health emergency but only after
the ethical considerations are
adequately addressed and reviewed.
The Commission is requesting public
comment on the ethical issues
associated with the development of
medical countermeasures for children,
including ethical considerations
surrounding clinical research with
children, ethical considerations
surrounding pediatric medical
countermeasure research, and ethical
considerations surrounding emergency
access to and use of medical
countermeasures. To this end, the
Commission is inviting interested
parties to provide input and advice
through written comments.
The Commission is particularly
interested in policies, practices,
research, and perspectives on ethical
issues associated with pre- and postevent studies testing the safety, dose,
and/or immunogenicity of medical
countermeasures for and with children.
Among other issues, specifically:
• How to conceptualize and consider
risk and societal value when reviewing
pediatric clinical research in general
and for medical countermeasures in
particular;
• the types of information, data, or
facts needed to ensure evidence-based
decision-making for conducting
pediatric medical countermeasure
research;
• possible criteria, if any, that might
classify proposed studies testing
medical countermeasures for pediatric
use as minimal risk;
• ethical issues related to access to
and allocation of medical
countermeasures previously studied
within pediatric populations in a public
health emergency;
• scientific and public health
strategies that could minimize the risk
or ethical concerns associated with
pediatric medical countermeasure
research;
• strategies for communicating risk to
prospective participants and their
families; and
• the role communities play in the
design and support of pediatric research
and pediatric medical countermeasure
research.
Please address comments by email to
info@bioethics.gov, or by mail to the
following address: Public Commentary,
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Presidential Commission for the Study
of Bioethical Issues, 1425 New York
Avenue NW., Suite C–100, Washington,
DC 20005. Comments will be publicly
available, including any personally
identifiable or confidential business
information that they contain. Trade
secrets should not be submitted.
Dated: June 15, 2012.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2012–15841 Filed 6–27–12; 8:45 am]
BILLING CODE 4154–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
SUMMARY:
E:\FR\FM\28JNN1.SGM
28JNN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 125 / Thursday, June 28, 2012 / Notices
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 + Manebinduced 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., CorySlechta, 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
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16:35 Jun 27, 2012
Jkt 226001
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.
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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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:
In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. App. 2, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality.
DATES: The meeting will be held on
Friday, July 13, 2012, from 8:30 a.m. to
3:30 p.m.
ADDRESSES: The meeting will be held at
the Eisenberg Conference Center,
Agency for Healthcare Research and
Quality, 540 Gaither Road, Rockville,
Maryland 20850.
FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Coordinator of the
Advisory Council, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland,
20850, (301) 427–1456. For press-related
information, please contact Alison Hunt
at (301) 427–1244.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than Friday,
March 16, 2012. The agenda, roster, and
minutes are available from Ms. Bonnie
Campbell, Committee Management
Officer, Agency for Healthcare Research
and Quality, 540 Gaither Road,
Rockville, Maryland, 20850. Ms.
Campbell’s phone number is (301) 427–
1554.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Purpose
The National Advisory Council for
Healthcare Research and Quality is
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Agencies
[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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]
BILLING CODE 4150-31-P