[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 723-724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00036]
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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: Findings of research misconduct have been made against
Alexander Neumeister, M.D. (Respondent), who was a Professor of
Psychiatry and Radiology, Department of Psychiatry, New York University
School of Medicine, Langone Medical Center (NYUSOM). Dr. Neumeister
engaged in research misconduct in psychiatric clinical research
supported by National Institute of Mental Health (NIMH), National
Institutes of Health (NIH), grants R01 MH096876, R01 MH102566, R21
MH094763, R21 MH096105, R21 MH102035, and R34 MH102871. The
administrative actions, including debarment for a period of two (2)
years, followed by supervision for a period of two (2) years, were
implemented beginning on December 13, 2019, and are detailed below.
FOR FURTHER INFORMATION CONTACT: Elisabeth A. Handley, Interim
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite
240, Rockville, MD 20852, (240) 453-8200.
SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of
Research Integrity (ORI) has taken final action in the following case:
Alexander Neumeister, M.D., New York University School of Medicine,
Langone Medical Center: Based on the report of an investigation
conducted by NYUSOM and additional analysis conducted by ORI in its
oversight review, ORI found that Dr. Alexander Neumeister, Professor of
Psychiatry and Radiology, Department of Psychiatry, NYUSOM, engaged in
research misconduct in psychiatric clinical research supported by NIMH,
NIH, grants R01 MH096876, R01 MH102566, R21 MH094763, R21 MH096105, R21
MH102035, and R34 MH102871.
Respondent neither admits nor denies ORI's findings of research
misconduct. The settlement is not an admission of liability on the part
of the Respondent. The parties entered into a Voluntary Exclusion
Agreement (Agreement) to conclude this matter without further
expenditure of time, finances, or other resources.
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, and/or recklessly falsifying and/or
fabricating data in the clinical records of research supported by six
(6) NIMH grants, resulting in the inclusion of falsified and/or
fabricated research methods and results in four (4) published papers:
Association of in vivo k-opioid receptor availability and
the transdiagnostic dimensional expression of trauma-related
psychopathology. JAMA Psychiatry 2014
[[Page 724]]
Nov;71(11):1262-70. Erratum in: JAMA Psychiatry 2014 Nov 7;71(11):1301.
Cannabinoid type 1 receptor availability in the amygdala
mediates threat processing in trauma survivors. Neuropsychopharmacology
39(11):2519-28, 2014 Oct.
Linking plasma cortisol levels to phenotypic heterogeneity
of posttraumatic stress symptomatology. Psychoneuroendocrinology 2014
Jan;39:88-93.
Association of posttraumatic stress disorder with reduced
in vivo norepinephrine transporter availability in the locus coeruleus.
JAMA Psychiatry 2013 Nov;70(11):1199-205.
Specifically, the Respondent misrepresented the characteristics of
the subjects entered in the research record by:
Combining data from multiple subjects to represent single
subjects to justify financial payments
changing and/or instructing his staff to change, omit, or
ignore clinical and psychiatric assessment data contained in the
electronic and/or written research records
failing to conduct and/or document screening tests (i.e.,
pregnancy tests, urine toxicology, electrocardiograms, blood alcohol
levels) to determine eligibility for each protocol
using outdated clinical and/or psychiatric assessments to
determine eligibility for experimental and control groups
reporting the utilization of trained and/or licensed personnel
to perform clinical and psychiatric assessments, when the specific
training, certification, and/or licensing had not been obtained
including in subsequent clinical research trials and their
associated publications, human research subjects' data that were
previously reported in:
--Positron emission tomography shows elevated cannabinoid CB1 receptor
binding in men with alcohol dependence. Alcohol Clin. Exp. Res. 2012
Dec;36(12):2104-9
This resulted in the inclusion of subjects in experimental and
control groups who did not meet the criteria for entry, as specified in
the protocols of the Respondent's funded grants, rendering the data
and/or published results invalid in the four (4) papers. The grants
are:
R01 MH096876, ``CB1 Receptor PET Imaging Reveals Gender
Differences in PTSD,'' project dates July 1, 2012-June 30, 2015
R01 MH102566, ``KOR Depression,'' project dates June 1, 2014-
June 30, 2015
R21 MH094763, ``CB1 Receptor Imaging in Anorexia,'' project
dates April 1, 2012-March 31, 2014
R21 MH096105, ``Kappa Opioid Receptor Imaging in PTSD,''
project dates April 1, 2012-March 31, 2015
R21 MH102035, ``Kappa Opioid Receptor Imaging in Anorexia,''
project dates August 20, 2013-June 30, 2015
R34 MH102871, ``A mGlu2/3 agonist in the treatment of PTSD,''
project dates July 9, 2014-June 30, 2015
Dr. Neumeister entered into an Agreement and agreed:
(1) To exclude himself voluntarily for a period of two (2) years,
beginning on December 13, 2019, 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) of OMB Guidelines to Agencies on
Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively
the ``Debarment Regulations''); at the conclusion of the period of
voluntary exclusion, Respondent agreed to have his research supervised
for a period of two (2) years; Respondent agreed that prior to
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 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; Respondent agreed 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 supervision
plan;
(2) to exclude himself voluntarily 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 four (4) years, beginning on December 13,
2019.
(3) as a condition of the Agreement, Respondent will utilize
information provided by ORI to request that the following papers be
corrected or retracted in accordance with 42 CFR 93.407(a)(1):
JAMA Psychiatry 2014 Nov;71(11):1262-70.
Neuropsychopharmacology 2014 Oct;39(11):2519-38.
Psychoneuroendocrinology 2014 Jan;39:88-93.
JAMA Psychiatry 2013 Nov;70(11):1199-205.
Respondent will copy ORI and the Research Integrity Officers at
NYUSOM and Yale University on the correspondence.
Elisabeth A. Handley,
Interim Director, Office of Research Integrity.
[FR Doc. 2020-00036 Filed 1-6-20; 8:45 am]
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