Findings of Research Misconduct, 723-724 [2020-00036]

Download as PDF Federal Register / Vol. 85, No. 4 / Tuesday, January 7, 2020 / Notices issuers offering non-grandfathered group or individual health insurance coverage. This 2019 update adds one additional service—Screening for Anxiety—to the HRSA-supported Women’s Preventive Services Guidelines to the 11 preventive services that were last updated in 2017. The 11 services included in the 2017 update are: Breast Cancer Screening for Average Risk Women, Breastfeeding Services and Supplies, Screening for Cervical Cancer, Contraception, Screening for Gestational Diabetes Mellitus, Screening for Human Immunodeficiency Virus Infection, Screening for Interpersonal and Domestic Violence, Counseling for Sexually Transmitted Infections, WellWoman Preventive Visits, Screening for Diabetes Mellitus after Pregnancy, and Screening for Urinary Incontinence. This notice serves as an announcement of the decision to update the guidelines as listed below. Please see https:// www.hrsa.gov/womens-guidelines/ index.html for additional information. FOR FURTHER INFORMATION CONTACT: Ada Determan, Maternal and Child Health Bureau at email: wellwomancare@ hrsa.gov or (301) 945–3057. SUPPLEMENTARY INFORMATION: The updated 2019 HRSA-supported Women’s Preventive Services Guidelines and information related to guideline development and implementation can be found on https:// www.hrsa.gov/womens-guidelines-2019/ index.html. Information regarding the new preventive service approved by the HRSA Administrator for inclusion in the comprehensive guidelines is set out below: Screening for Anxiety khammond on DSKJM1Z7X2PROD with NOTICES The Women’s Preventive Services Initiative recommends screening for anxiety in adolescent and adult women, including those who are pregnant or postpartum. Optimal screening intervals are unknown and clinical judgement should be used to determine screening frequency. Given the high prevalence of anxiety disorders, lack of recognition in clinical practice, and multiple problems associated with untreated anxiety, clinicians should consider screening women who have not been recently screened. HRSA-Supported Women’s Preventive Services Guidelines The HRSA-supported Women’s Preventive Services Guidelines were originally established in 2011 based on recommendations from the Institute of Medicine, now known as the National Academy of Medicine (NAM), developed under a contract with HHS. VerDate Sep<11>2014 16:15 Jan 06, 2020 Jkt 250001 Since then, there have been advancements in science and gaps identified in the existing guidelines, including a greater emphasis on practice-based clinical considerations. To address these, HRSA awarded a 5year cooperative agreement in March 2016 to convene a coalition of clinician, academic, and consumer-focused health professional organizations and conduct a scientifically rigorous review to develop recommendations for updated Women’s Preventive Services Guidelines in accordance with the model created by the NAM Clinical Practice Guidelines We Can Trust. The American College of Obstetricians and Gynecologists was awarded the cooperative agreement and formed an expert panel called the Women’s Preventive Services Initiative to perform this work. Under section 2713 of the Public Health Service Act, 42 U.S.C. 300gg–13, non-grandfathered group health plans and issuers of non-grandfathered group and individual health insurance coverage are required to cover specified preventive services without a copayment, coinsurance, deductible, or other cost sharing, including preventive care and screenings for women as provided for in comprehensive guidelines supported by HRSA for this purpose. Non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual coverage (generally plans or policies created or sold after March 23, 2010, or older plans or policies that have been changed in certain ways since that date) are required to provide coverage without cost sharing for preventive services listed in the updated HRSA-supported guidelines (which include the 11 preventive services last updated in 2017 as well as the one new service added in this update) beginning with the first plan year (in the individual market, policy year) that begins on or after December 17, 2020. Dated: December 30, 2019. Thomas J. Engels, Administrator. [FR Doc. 2020–00035 Filed 1–6–20; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 723 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 SUMMARY: E:\FR\FM\07JAN1.SGM 07JAN1 khammond on DSKJM1Z7X2PROD with NOTICES 724 Federal Register / Vol. 85, No. 4 / Tuesday, January 7, 2020 / Notices 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 VerDate Sep<11>2014 16:15 Jan 06, 2020 Jkt 250001 • 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 PHSsupported 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 PHSsupported 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. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 • 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel; NIDCR Clinical Research SEP. Date: February 12, 2020. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Yun Mei, MD, Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Suite #672, Bethesda, Maryland 20892, 301–827–4639, yun.mei@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: December 31, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–28512 Filed 1–6–20; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\07JAN1.SGM 07JAN1

Agencies

[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]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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
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