80_FR_18704 80 FR 18638 - Findings of Research Misconduct

80 FR 18638 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 66 (April 7, 2015)

Page Range18638-18639
FR Document2015-07897

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Ryousuke Fujita, Ph.D., Columbia University: Based on the report of an investigation conducted by Columbia University (CU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Ryousuke Fujita, former Postdoctoral Scientist, Taub Institute for the Aging Brain, Departments of Pathology and Cell Biology and Neurology, CU Medical Center, engaged in research misconduct in research supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS064433 and National Institute of Aging (NIA), NIH, grant R01 AG042317. ORI found that Respondent engaged in research misconduct by falsifying and fabricating data for specific protein expressions in human-induced neuronal (hiN) cells derived skin fibroblasts of Alzheimer's disease patients and unaffected individuals in seventy-four (74) panels included in figures in the following two (2) publications and one (1) unpublished manuscript: <bullet> Cell 146:359-371, 2011 (hereafter referred to as ``Cell 2011''). <bullet> Nature 500:45-53, 2013 (hereafter referred to as ``Nature 2013''). <bullet> ``Human induced neuron models of APOE4-associated Alzheimer's disease display altered APP endocytosis and processing.'' Unpublished manuscript. ORI found that Respondent engaged in research misconduct by knowingly and intentionally fabricating and falsifying research in seventy-four (74) panels included in figures in Cell 2011, Nature 2013, and the unpublished manuscript. Respondent inflated sample numbers and data, fabricated numbers for data sets, manipulated enzyme-linked immunosorbent assay (ELISA) analysis, mislabelled immunoflourescent confocal images, and manipulated and reused Western blot images.

Federal Register, Volume 80 Issue 66 (Tuesday, April 7, 2015)
[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Pages 18638-18639]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07897]


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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.

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

SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Ryousuke Fujita, Ph.D., Columbia University: Based on the report of 
an investigation conducted by Columbia University (CU) and additional 
analysis conducted by ORI in its oversight review, ORI found that Dr. 
Ryousuke Fujita, former Postdoctoral Scientist, Taub Institute for the 
Aging Brain, Departments of Pathology and Cell Biology and Neurology, 
CU Medical Center, engaged in research misconduct in research supported 
by National Institute of Neurological Disorders and Stroke (NINDS), 
National Institutes of Health (NIH), grant R01 NS064433 and National 
Institute of Aging (NIA), NIH, grant R01 AG042317.
    ORI found that Respondent engaged in research misconduct by 
falsifying and fabricating data for specific protein expressions in 
human-induced neuronal (hiN) cells derived skin fibroblasts of 
Alzheimer's disease patients and unaffected individuals in seventy-four 
(74) panels included in figures in the following two (2) publications 
and one (1) unpublished manuscript:
     Cell 146:359-371, 2011 (hereafter referred to as ``Cell 
2011'').
     Nature 500:45-53, 2013 (hereafter referred to as ``Nature 
2013'').
     ``Human induced neuron models of APOE4-associated 
Alzheimer's disease display altered APP endocytosis and processing.'' 
Unpublished manuscript.
    ORI found that Respondent engaged in research misconduct by 
knowingly and intentionally fabricating and falsifying research in 
seventy-four (74)

[[Page 18639]]

panels included in figures in Cell 2011, Nature 2013, and the 
unpublished manuscript. Respondent inflated sample numbers and data, 
fabricated numbers for data sets, manipulated enzyme-linked 
immunosorbent assay (ELISA) analysis, mislabelled immunoflourescent 
confocal images, and manipulated and reused Western blot images.

Specifically, the Respondent

 Fabricated numbers for the data presented as a bar graph in 
nine (9) panels in Figures S6#, S6H, and S6J in Cell 2011, Figures 3B 
and S12 in Nature 2013, and Figures 2F, 4B, 4D, and 4F in the 
unpublished manuscript
Falsely inflated the sample size of quantitative data presented as bar 
graphs in fifty-three (53) panels in Figures 6B, 7I, and S6J in Cell 
2011, Figures 3G, 3H, 4C, S10, S11b-h, S12d-f, S13a, S13c, S14b-c, 
S15b-i, and S16a-f in Nature 2013, and Figures 4b, 4d, 4f, 4i, 6c-d, 
S1n, S1o, S2a-b, and S4c-k in the unpublished manuscript
Falsely manipulated ELISA analysis to achieve desired results presented 
as bar graphs in nine (9) figure-panels in Figure 6B in Cell 2011 and 
Figures 2D, 2E, 3G, 3H, and S10a-d in Nature 2013
Falsely inflated the numerical values of the data in Figure 7I in Cell 
2011 by a factor of 10 to improve results and appear consistent with 
data presented in supplementary information published with the paper
Falsely reversed the labeling of immunoflourescent confocal images in 
Figures 7M and 7N in Cell 2011 and Figure S13A in Nature 2013 to obtain 
the desired results
Flipped and resized the Western blot image for APP panel from Figure 
12b and falsely reused it to represent APP results under completely 
different experimental conditions in Figure 12c in Nature 2013

    Dr. Fujita has entered into a Voluntary Exclusion Agreement 
(Agreement) and has voluntarily agreed for a period of three (3) years, 
beginning on March 18, 2015:
    (1) to exclude himself 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 et seq) of OMB Guidelines to Agencies on Governmentwide 
Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment 
Regulations''); and
    (2) to exclude himself voluntarily from serving in any advisory 
capacity to the U.S. Public Health Service (PHS) including, but not 
limited to, service on any PHS advisory committee, board, and/or peer 
review committee, or as a consultant.

FOR FURTHER INFORMATION CONTACT: Acting Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8200.

Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015-07897 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 4150-31-P



                                                  18638                           Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices

                                                  RECORD SOURCE CATEGORIES:                               were included in five (5) publications                and/or peer review committee, or as a
                                                     Records are obtained directly from the               and three (3) grant applications                      consultant; and
                                                  subject individuals, or from the                        submitted to NINR, NIH:                                 (3) to request that the following
                                                  following sources: educational                          Behavioural Brain Research 279:112–22,                publications be retracted: BBR 2015, JNI
                                                  institutions; internship and/or residency                  2015 Feb 15 (hereafter referred to as              2014, JNT 2009, JNT 2011, and NS 2014.
                                                  training programs; employers; NHSC-                        ‘‘BBR 2015’’)                                      FOR FURTHER INFORMATION CONTACT:
                                                  approved service sites; critical shortage               • Journal of Neuroinflammation 11:13,                 Acting Director, Office of Research
                                                  facilities; schools of nursing; lending                    2014 Jan 22 (hereafter referred to as              Integrity, 1101 Wootton Parkway, Suite
                                                  institutions and loan servicing agencies;                  ‘‘JNI 2014’’)                                      750, Rockville, MD 20852, (240) 453–
                                                  health professional associations;                       • Journal of Neurotrauma 26(4):613–25,                8200.
                                                  National Practitioner Data Bank; System                    2009 Apr (hereafter referred to as
                                                  for Awards Management (formerly                                                                               Donald Wright,
                                                                                                             ‘‘JNT 2009’’)
                                                                                                                                                                Acting Director, Office of Research Integrity.
                                                  Excluded Parties List System); HHS                      • Journal of Neurotrauma 28(12):2485–
                                                  Office of Inspector General Web site                       92, 2011 Dec (hereafter referred to as             [FR Doc. 2015–07896 Filed 4–6–15; 8:45 am]
                                                  listing of individuals excluded from                       ‘‘JNT 2011’’)                                      BILLING CODE CODE 4150–31–P
                                                  Medicare, Medicaid, and all other                       • Neuroscience 262:143–55, 2014 Mar
                                                  federal health care programs; HHS                          14 (hereafter referred to as ‘‘NS 2014’’)
                                                  database of Health Professional Shortage                • R01 NR011167–01                                     DEPARTMENT OF HEALTH AND
                                                  Areas; HHS grantees and contractors/                    • R01 NR011167–01A1                                   HUMAN SERVICES
                                                  subcontractors; consumer reporting                      • R01 NR 011167–01A2
                                                  agencies/credit bureaus; other federal                                                                        Office of the Secretary
                                                                                                             ORI found that Respondent falsified
                                                  agencies, including but not limited to                  and/or fabricated data by falsely                     Findings of Research Misconduct
                                                  the Department of the Treasury, IRS,                    reporting the results of Western blot
                                                  and the U.S. Postal Service; state health               experiments that examined                             AGENCY:   Office of the Secretary, HHS.
                                                  professions licensing boards and/or the                 neuroinflammation, amyloidogenesis,                   ACTION:   Notice.
                                                  Federation of State Medical Boards or a                 and/or cognitive impairment in a rat
                                                  similar non-government entity; and                                                                            SUMMARY:   Notice is hereby given that
                                                                                                          model of cerebral ischemia. Specifically,
                                                  third parties who provide references or                                                                       the Office of Research Integrity (ORI)
                                                                                                          Respondent duplicated, reused, and
                                                  other information concerning the                                                                              has taken final action in the following
                                                                                                          falsely relabeled Western blot gel images
                                                  subject individual.                                                                                           case:
                                                                                                          and claimed they represented different                  Ryousuke Fujita, Ph.D., Columbia
                                                  SYSTEM EXEMPTED FROM CERTAIN PROVISIONS                 experiments in:                                       University: Based on the report of an
                                                  OF THE ACT:                                             • BBR 2015, Figures 2E and 5D                         investigation conducted by Columbia
                                                     None.                                                • JNI 2014, Figures 2A and 2C                         University (CU) and additional analysis
                                                  [FR Doc. 2015–07899 Filed 4–6–15; 8:45 am]
                                                                                                          • JNT 2009, Figures 2B and 5                          conducted by ORI in its oversight
                                                                                                          • JNT 2011, Figure 2                                  review, ORI found that Dr. Ryousuke
                                                                                                          • NS 2014, Figure 4
                                                  BILLING CODE CODE 4160–15–P
                                                                                                                                                                Fujita, former Postdoctoral Scientist,
                                                                                                          • R01 NR011167–01, Figures 5 and 6                    Taub Institute for the Aging Brain,
                                                  DEPARTMENT OF HEALTH AND                                • R01 NR011167–01A1, Figures 4A and                   Departments of Pathology and Cell
                                                  HUMAN SERVICES                                             4B                                                 Biology and Neurology, CU Medical
                                                                                                          • R01 NR011167–01A2, Figures 4A and
                                                                                                                                                                Center, engaged in research misconduct
                                                  Office of the Secretary                                    4B
                                                                                                                                                                in research supported by National
                                                                                                             As a result of this Agreement,                     Institute of Neurological Disorders and
                                                  Findings of Research Misconduct                         Respondent will request that the                      Stroke (NINDS), National Institutes of
                                                  AGENCY:   Office of the Secretary, HHS.                 following publications be retracted: BBR              Health (NIH), grant R01 NS064433 and
                                                                                                          2015, JNI 2014, JNT 2009, JNT 2011, and               National Institute of Aging (NIA), NIH,
                                                  ACTION:   Notice.
                                                                                                          NS 2014.                                              grant R01 AG042317.
                                                  SUMMARY:   Notice is hereby given that                     Dr. Briones has entered into a                       ORI found that Respondent engaged
                                                  the Office of Research Integrity (ORI)                  Voluntary Exclusion Agreement                         in research misconduct by falsifying and
                                                  has taken final action in the following                 (Agreement) and has voluntarily agreed                fabricating data for specific protein
                                                  case:                                                   for a period of three (3) years, beginning            expressions in human-induced neuronal
                                                     Teresita L. Briones, Ph.D., Wayne                    on March 12, 2015:                                    (hiN) cells derived skin fibroblasts of
                                                  State University: Based on the report of                   (1) to exclude herself from any                    Alzheimer’s disease patients and
                                                  an inquiry conducted by Wayne State                     contracting or subcontracting with any                unaffected individuals in seventy-four
                                                  University (WSU) and additional                         agency of the United States Government                (74) panels included in figures in the
                                                  analysis conducted by ORI in its                        and from eligibility for or involvement               following two (2) publications and one
                                                  oversight review, ORI found that Dr.                    in nonprocurement programs of the                     (1) unpublished manuscript:
                                                  Teresita L. Briones, former Associate                   United States Government referred to as                 • Cell 146:359–371, 2011 (hereafter
                                                  Professor, College of Nursing, WSU,                     ‘‘covered transactions’’ pursuant to                  referred to as ‘‘Cell 2011’’).
                                                  engaged in research misconduct in                       HHS’ Implementation (2 CFR part 376 et                  • Nature 500:45–53, 2013 (hereafter
                                                  research supported by National Institute                seq) of OMB Guidelines to Agencies on                 referred to as ‘‘Nature 2013’’).
                                                                                                                                                                   • ‘‘Human induced neuron models of
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                                                  of Nursing Research (NINR), National                    Governmentwide Debarment and
                                                  Institutes of Health (NIH), grants P30                  Suspension, 2 CFR part 180 (collectively              APOE4-associated Alzheimer’s disease
                                                  NR009014, R01 NR005260, and R01                         the ‘‘Debarment Regulations’’);                       display altered APP endocytosis and
                                                  NR007666.                                                  (2) to exclude herself voluntarily from            processing.’’ Unpublished manuscript.
                                                     ORI found that Respondent                            serving in any advisory capacity to the                  ORI found that Respondent engaged
                                                  intentionally, knowingly, and recklessly                U.S. Public Health Service (PHS)                      in research misconduct by knowingly
                                                  engaged in research misconduct by                       including, but not limited to, service on             and intentionally fabricating and
                                                  falsifying and/or fabricating data that                 any PHS advisory committee, board,                    falsifying research in seventy-four (74)


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                                                                                  Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices                                                 18639

                                                  panels included in figures in Cell 2011,                   (2) to exclude himself voluntarily                 Preparedness Reauthorization Act of
                                                  Nature 2013, and the unpublished                        from serving in any advisory capacity to              2013 (Pub. L. 113–5), the HHS
                                                  manuscript. Respondent inflated sample                  the U.S. Public Health Service (PHS)                  Secretary, in consultation with the
                                                  numbers and data, fabricated numbers                    including, but not limited to, service on             Secretary of the U.S. Department of
                                                  for data sets, manipulated enzyme-                      any PHS advisory committee, board,                    Homeland Security, established the
                                                  linked immunosorbent assay (ELISA)                      and/or peer review committee, or as a                 National Advisory Committee on
                                                  analysis, mislabelled                                   consultant.                                           Children and Disasters (NACCD). The
                                                  immunoflourescent confocal images,                      FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                purpose of the NACCD is to provide
                                                  and manipulated and reused Western                                                                            advice and consultation to the HHS
                                                                                                          Acting Director, Office of Research
                                                  blot images.                                                                                                  Secretary with respect to the medical
                                                                                                          Integrity, 1101 Wootton Parkway, Suite
                                                  Specifically, the Respondent                            750, Rockville, MD 20852, (240) 453–                  and public health needs of children in
                                                                                                          8200.                                                 relation to disasters. The Office of the
                                                  • Fabricated numbers for the data                                                                             Assistant Secretary for Preparedness
                                                     presented as a bar graph in nine (9)                 Donald Wright,                                        and Response (ASPR) provides
                                                     panels in Figures S6#, S6H, and S6J                  Acting Director, Office of Research Integrity.        management and administrative
                                                     in Cell 2011, Figures 3B and S12 in                  [FR Doc. 2015–07897 Filed 4–6–15; 8:45 am]            oversight to support the activities of the
                                                     Nature 2013, and Figures 2F, 4B, 4D,                                                                       NACCD.
                                                                                                          BILLING CODE CODE 4150–31–P
                                                     and 4F in the unpublished                                                                                    Background: This public meeting will
                                                     manuscript                                                                                                 be dedicated to the members voting to
                                                  Falsely inflated the sample size of                     DEPARTMENT OF HEALTH AND                              approve the report of findings of the
                                                     quantitative data presented as bar                                                                         NACCD Surge Capacity Work Group.
                                                                                                          HUMAN SERVICES
                                                     graphs in fifty-three (53) panels in                                                                         Availability of Materials: The meeting
                                                     Figures 6B, 7I, and S6J in Cell 2011,                Meeting of the National Advisory                      agenda and materials will be posted on
                                                     Figures 3G, 3H, 4C, S10, S11b–h,                     Committee on Children and Disasters                   the NACCD Web site at: www.phe.gov/
                                                     S12d–f, S13a, S13c, S14b–c, S15b–i,                                                                        naccd prior to the meeting.
                                                     and S16a–f in Nature 2013, and                       AGENCY:  Office of the Secretary,                       Procedures for Providing Public Input:
                                                     Figures 4b, 4d, 4f, 4i, 6c–d, S1n, S1o,              Department of Health and Human                        All written comments must be received
                                                     S2a–b, and S4c–k in the unpublished                  Services.                                             prior to April 29, 2015. Please submit
                                                     manuscript                                           ACTION: Notice.                                       comments via the NACCD Contact Form
                                                  Falsely manipulated ELISA analysis to                                                                         located at www.phe.gov/
                                                     achieve desired results presented as                 SUMMARY:    As stipulated by the Federal
                                                                                                                                                                NACCDComments. Individuals who
                                                     bar graphs in nine (9) figure-panels in              Advisory Committee Act, the
                                                                                                                                                                plan to participate by phone and need
                                                     Figure 6B in Cell 2011 and Figures                   Department of Health and Human
                                                                                                                                                                special assistance should submit a
                                                     2D, 2E, 3G, 3H, and S10a–d in Nature                 Services (HHS) is hereby giving notice
                                                                                                                                                                request via the NACCD Contact Form
                                                     2013                                                 that the National Advisory Committee
                                                                                                                                                                located at www.phe.gov/
                                                  Falsely inflated the numerical values of                on Children and Disasters (NACCD) will
                                                                                                                                                                NACCDComments.
                                                     the data in Figure 7I in Cell 2011 by                be holding a meeting via teleconference.
                                                     a factor of 10 to improve results and                The meeting is open to the public.                      Dated: March 18, 2015.
                                                     appear consistent with data presented                DATES: The April 30, 2015, NACCD                      Nicole Lurie,
                                                     in supplementary information                         meeting is scheduled from 1:00 p.m. to                Assistant Secretary for Preparedness and
                                                     published with the paper                             2:00 p.m. EST. The agenda is subject to               Response.
                                                  Falsely reversed the labeling of                        change as priorities dictate. Please                  [FR Doc. 2015–07874 Filed 4–6–15; 8:45 am]
                                                     immunoflourescent confocal images                    check the NACCD Web site, located at                  BILLING CODE CODE P
                                                     in Figures 7M and 7N in Cell 2011                    WWW.PHE.GOV/NACCD for the most
                                                     and Figure S13A in Nature 2013 to                    up-to-date information on the meeting.
                                                     obtain the desired results                           ADDRESSES: To attend the meeting via
                                                                                                                                                                DEPARTMENT OF HEALTH AND
                                                  Flipped and resized the Western blot                                                                          HUMAN SERVICES
                                                                                                          teleconference, call toll-free: 1–888–
                                                     image for APP panel from Figure 12b
                                                                                                          324–4311, international dial-in: 1–517–               Indian Health Service
                                                     and falsely reused it to represent APP
                                                                                                          308–9181. The pass-code is: 4818002.
                                                     results under completely different
                                                                                                          Please call 15 minutes prior to the                   Reimbursement Rates for Calendar
                                                     experimental conditions in Figure 12c
                                                                                                          beginning of the conference call to                   Year 2015
                                                     in Nature 2013
                                                                                                          facilitate attendance. Pre-registration is
                                                     Dr. Fujita has entered into a Voluntary              required for public attendance.                       AGENCY:   Indian Health Service, HHS.
                                                  Exclusion Agreement (Agreement) and                     Individuals who wish to attend the                    ACTION:   Notice.
                                                  has voluntarily agreed for a period of                  meeting should submit an inquiry via
                                                  three (3) years, beginning on March 18,                 the NACCD Contact Form located at                     SUMMARY:   Notice is given that the
                                                  2015:                                                   www.phe.gov/NACCDComments.                            Director of the Indian Health Service
                                                     (1) to exclude himself from any                                                                            (IHS), under the authority of sections
                                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                  contracting or subcontracting with any                                                                        321(a) and 322(b) of the Public Health
                                                  agency of the United States Government                  Please submit an inquiry via the NACCD                Service Act (42 U.S.C. 248 and 249(b)),
                                                  and from eligibility for or involvement                 Contact Form located at www.phe.gov/                  Public Law 83–568 (42 U.S.C. 2001(a)),
                                                                                                          NACCDComments.
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                                                  in nonprocurement programs of the                                                                             and the Indian Health Care
                                                  United States Government referred to as                 SUPPLEMENTARY INFORMATION:   Pursuant                 Improvement Act (25 U.S.C. 1601 et
                                                  ‘‘covered transactions’’ pursuant to                    to the Federal Advisory Committee Act                 seq.), has approved the following rates
                                                  HHS’ Implementation (2 CFR part 376 et                  (FACA) of 1972 (5 U.S.C., Appendix, as                for inpatient and outpatient medical
                                                  seq) of OMB Guidelines to Agencies on                   amended), and section 2811A of the                    care provided by IHS facilities for
                                                  Governmentwide Debarment and                            Public Health Service (PHS) Act (42                   Calendar Year 2015 for Medicare and
                                                  Suspension, 2 CFR part 180 (collectively                U.S.C. 300hh–10a), as added by section                Medicaid beneficiaries, and
                                                  the ‘‘Debarment Regulations’’); and                     103 of the Pandemic and All Hazards                   beneficiaries of other Federal programs,


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Document Created: 2018-02-21 10:05:22
Document Modified: 2018-02-21 10:05:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactActing Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation80 FR 18638 

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