[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11538-11539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4366]
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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:
Michael W. Miller, Ph.D., State University of New York, Upstate
Medical University: Based on the report of an investigation conducted
by the State University of New York, Upstate Medical University (SUNY
UMU) and additional analysis conducted by ORI in its oversight review,
ORI found that Dr. Michael W. Miller, former Professor and Chair,
Department of Neuroscience and Physiology, SUNY UMU, engaged in
research misconduct in research supported by National Institute of
Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health
(NIH), grants R01 AA07568-18A1, R01 AA06916, and P50 AA017823-01.
ORI finds that the Respondent engaged in research misconduct by
falsifying and/or fabricating data that were included in grant
applications R01 AA07568-18, R01 AA07568-18A1, R01 AA006916-25, and P50
AA017823-01 and in the following:
Miller, M.W., Hu, H. ``Lability of neuronal lineage
decisions is revealed by acute exposures to ethanol.'' Dev. Neurosci.
31(1-2):50-7, 2009 (``Dev. Neurosci. 2009'')
Bruns, M.B., Miller, M.W. ``Functional nerve growth factor
and trkA autocrine/paracrine circuits in adult rat cortex are revealed
by episodic ethanol exposure and withdrawal.'' J. Neurochem.
100(5):1115-68, 2007 (``J. Neurochem. 2007'')
A prepared manuscript submitted to PNAS for publication.
As a result of its investigation, SUNY UMU recommended that Dev.
Neurosci. 2009 and J. Neurochem. 2007 be retracted. Both publications
have now been retracted:
Dev. Neurosci. 2009 was retracted online on January 19,
2012, at: http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=323471&Ausgabe=0&ProduktNr=224107&filename=323471.pdf.
J. Neurochem. 2007 was retracted online on January 23,
2012, at: http://onlinelibrary.wiley.com/doi/10.1111/j.1471-4159.2012.07662.x/full.
Specifically, ORI finds that the Respondent:
Falsified Figure 5 in NIH grant application R01 AA07568-
18A1 by altering the bar graphs to make the experimental results appear
valid and consistent with his hypothesis that ethanol exposure in-utero
alters the transition of cells from Pax 6 expression to Tbr2
expression, which is critical to normal brain development.
Specifically:
a. In the VZ/SZ panel (upper row, right), Dr. Miller decreased the
values by 50% for the bar graphs representing control and treated mice
for ``Tbr2,'' ``both,'' and ``both/Ki-67,'' to falsely report an
equivalent frequency of Tbr2 expressing cells in the right and left
panels; this result was required for the experiment to appear valid;
b. In the MGE panel (lower row, right), Dr. Miller altered the bar
graphs representing control and treated mice for ``Ki-67,'' ``Pax6,''
and ``both'' to falsely report that ethanol increased the frequency of
K-67+ cells and to report an equivalent frequency of Pax expressing
cells in the right and left panels.
Fabricated bar graphs in Supplemental Figure 2 in a
manuscript submitted to PNAS and text in the manuscript also appearing
in the grant application AA00616-25 to support the hypothesis that
ethanol exposure during postnatal weeks 1 and 2 causes specific
neuronal cell death in layers II/III and V of the cortex. Specifically,
Dr. Miller:
a. Fabricated bar graphs in Supplemental Figure 2 and related text
in the PNAS manuscript to show that in select layers of the cortex,
ethanol induced neuronal death occurred in post-natal day 10 (P10)
mice;
b. Included fabricated text in the PNAS manuscript and the grant
application citing results of experiments using 15-25-day-old mice
treated with ethanol during the second postnatal week, when these mice
were never generated.
Falsified Figure 6 in a manuscript submitted to PNAS by
altering data points for the labeling index of caspase3 and TUNEL in
cortex layers II/III and V after exposure to ethanol in postnatal day 7
(P7) mice, such that the two assays confirmed each other. The same data
were also included as Figure 4 in NIH grant application R01 AA06916 and
as Figure 7 in a poster presentation at the 2009 Research Society on
Alcoholism.
Falsified the figure legends and/or text in a published
paper and multiple grant applications to support the primary hypothesis
of the published paper that gestational alcohol exposure had an effect
on brain development by affecting the way neurons differentiate and
migrate into the cortex, rather than by changes to cell growth or
death. Specifically, Dr. Miller falsely reported the number of animals
(n) that were used in figure legends and/or text in the following:
[cir] Figures 2 and 5, Dev. Neurosci. 2009, also included as
Figures 3 and 4, respectively, in R01 AA07568-18;
[cir] Figure 4 and Table 2 in P50 AA017823-01.
Falsified Figures 4 and 6 in J. Neurochem. 2007 by
altering bar graphs to increase the significance of the effect of
ethanol exposure and/or withdrawal on NGF or trkA protein expression,
thereby conforming with the paper's hypothesis that ethanol exposure
and withdrawal affect the normal NGF/trkA circuits in cortical layer V.
Specifically, Dr. Miller:
a. Increased the value of the ethanol treated NGF expression in
Figure 4 and decreased the value of withdrawal NFG to alter the
difference between the two from approximately 2.2% to 11.6%, thereby
falsely reporting significance where there was none;
b. In Figure 6:
(a) Increased the value of withdrawal trkA data by approximately
70% to falsely report significance with relation to the ethanol treated
value and increase significance with relation to the control;
(b) Increased the value of the ethanol treated phospho-trkA data by
approximately 100% to increase the significance with relation to the
control;
(c) Falsely reported the results for Figure 6 as showing a nearly
doubled ratio of p-trkA to total trkA after ethanol exposure when there
was no increase at all.
Dr. Miller has entered into a Voluntary Exclusion Agreement
(Agreement). Dr. Miller neither admits nor denies committing research
misconduct but accepts ORI has found evidence of research misconduct as
set forth above.
Dr. Miller has voluntarily agreed:
(1) To exclude himself voluntarily 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
[[Page 11539]]
Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations'')
for a period of one (1) year, beginning on February 6, 2012;
(2) To have his research supervised for a period of two (2) years
immediately following the one (1) year period of exclusion; Respondent
agrees that prior to the submission of an application for U.S. Public
Health Service (PHS) support for a research project on which the
Respondent's participation is proposed and prior to the 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 Respondent's research contribution
as outlined below; Respondent agrees that he shall not participate in
any PHS-supported research until such a supervision plan is submitted
to and approved by ORI; Respondent agrees to maintain responsibility
for compliance with the agreed upon supervision plan; 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 two (2) years immediately following the period of
exclusion; 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, Respondent's
compliance with appropriate research standards, and confirming the
integrity of Respondent's research; and
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 include a certification to ORI
that the data presented in the proposed application/publication is
supported by the research record;
(3) That any institution employing him during the two (2) years
during which the supervisory plan is in effect shall submit, in
conjunction with each application for 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; and
(4) To exclude himself 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 February 6, 2012.
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. 2012-4366 Filed 2-24-12; 8:45 am]
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