[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]
 BILLING CODE 4150-31-P