[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:
    <bullet> 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'')
    <bullet> 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'')
    <bullet> 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have now been retracted:
    <bullet> 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 Neurosci. 2009 was retracted online on January 19, 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.
    <bullet> J. Neurochem. 2007 was retracted online on January 23, 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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]
BILLING CODE 4150-31-P