81_FR_59810 81 FR 59642 - Findings of Research Misconduct

81 FR 59642 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 81, Issue 168 (August 30, 2016)

Page Range59642-59643
FR Document2016-20834

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Andrew R. Cullinane, Ph.D., National Institutes of Health: Based on Respondent's admission, an assessment conducted by the National Institutes of Health (NIH), and analysis conducted by ORI in its oversight review, ORI found that Dr. Andrew R. Cullinane, former postdoctoral fellow, Medical Genetics Branch, National Human Genome Research Institute (NHGRI), NIH, engaged in research misconduct in research supported by NHGRI, NIH. ORI found that Respondent engaged in research misconduct by reporting falsified and/or fabricated data in the following two (2) publications and one (1) submitted manuscript:

Federal Register, Volume 81 Issue 168 (Tuesday, August 30, 2016)
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59642-59643]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20834]


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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:
    Andrew R. Cullinane, Ph.D., National Institutes of Health: Based on 
Respondent's admission, an assessment conducted by the National 
Institutes of Health (NIH), and analysis conducted by ORI in its 
oversight review, ORI found that Dr. Andrew R. Cullinane, former 
postdoctoral fellow, Medical Genetics Branch, National Human Genome 
Research Institute (NHGRI), NIH, engaged in research misconduct in 
research supported by NHGRI, NIH.
    ORI found that Respondent engaged in research misconduct by 
reporting falsified and/or fabricated data in the following two (2) 
publications and one (1) submitted manuscript:

 Am. J. Hum. Genet. 88(6):778-787, 2011 (hereafter referred to 
as ``Paper 1'')
 Neurology 86(14):1320-1328, 2016 (hereafter referred to as 
``Paper 2'')
 ``RAB11FIP1, Mutated in HPS-10, Interacts with BLOC-1 to 
Mitigate Recycling of Melanogenic Proteins.'' Submitted for publication 
to The Journal of Clinical Investigations, Cell, Nature Biology, 
Molecular Cell, and Nature Genetics (hereafter referred to as 
``Manuscript 1'')

    ORI found that Respondent knowingly falsified and/or fabricated 
data and related images by alteration and/or reuse and/or relabeling of 
experimental data. Specifically:

 in Paper 1, Respondent falsified and/or fabricated the results 
in Figure 3C by using the same gel images to represent expression of 
PLDN in fibroblasts and melanocytes
 in Paper 2, Respondent falsified and/or fabricated the results 
in Figure 2A by erasure of a band in the blot image for LYST/CHD-4 that 
was present in the original data
 in Manuscript 1, Respondent falsified and/or fabricated the 
results in Western blot data by reuse and relabeling, duplication, and/
or manipulation in Figures 2B, 2D, 2E, 3A-C, 4C, 4E, 4G, 5B, 6A-C, 7A, 
7D, 7G, 7J, and Supplemental Figure 3, and Respondent falsified and/or 
fabricated the results by reuse and relabeling of centrifuge tubes to 
represent different experiments in Figures 1D, 7C, 7F, 7I, 7L, and 
Supplemental Figure 2

    Dr. Cullinane has entered into a Voluntary Settlement Agreement 
with ORI and NIH, in which he voluntarily agreed:
    (1) To have his research supervised for a period of three (3) years 
beginning on July 22, 2016; Respondent agreed to ensure that prior to 
the submission of an application for U.S. Public Health Service (PHS) 
support for a research project on which Respondent's participation is 
proposed and prior to Respondent's participation in any capacity on 
PHS-supported research, the institution employing him must submit a 
plan for supervision of his duties to ORI for approval. The plan for 
supervision must be designed to ensure the scientific integrity of 
Respondent's research contribution; Respondent agreed that he will not 
participate in any PHS-supported research until a plan for supervision 
is submitted to and approved by ORI; Respondent agreed to maintain 
responsibility for compliance with the agreed upon supervision plan;
    (2) that for a period of three (3) years beginning on July 22, 
2016, any institution employing him 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;
    (3) 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 July 22, 2016; and
    (4) as a condition of the Agreement, Respondent agreed to the 
retraction or correction of:

 Am. J. Hum. Genet. 88(6):778-787, 2011

[[Page 59643]]

 Neurology 86(14):1320-1328, 2016

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

Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2016-20834 Filed 8-29-16; 8:45 am]
 BILLING CODE 4150-31-P



                                                  59642                                  Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices

                                                    Burden Statement: Burden in this                                         technology and systems for the purpose                          data sources; (7) completing and
                                                  context means the time expended by                                         of collecting, validating and verifying                         reviewing the collection of information;
                                                  persons to generate, maintain, retain,                                     information; (3) processing and                                 and (8) transmitting or otherwise
                                                  disclose or provide the information                                        maintaining information; (4) disclosing                         disclosing the information. The total
                                                  requested. This includes (1) the time                                      and providing information; (5) training                         annual burden hours estimated for this
                                                  needed to review instructions; (2) to                                      personnel to be able to respond to a                            ICR are summarized in the table below.
                                                  develop, acquire, install and utilize                                      collection of information; (6) searching

                                                                                                                   TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                                  Average
                                                                                                                                                                    Number of
                                                                                                                                                Number of                                       Total           burden per              Total burden
                                                                                     Form name                                                                    responses per
                                                                                                                                               respondents                                   responses           response                  hours
                                                                                                                                                                    respondent                                   (in hours)

                                                  Baseline Pre-TED (Transplant Essential Data) ...................                                          200                       44           8,800                     1.15             10,120
                                                  Product Form (includes Infusion, HLA, and Infectious Dis-
                                                    ease Marker inserts) ........................................................                           200                      33            6,600                        1              6,600
                                                  100-Day Post-TED ...............................................................                          200                      44            8,800                     1.25             11,000
                                                  6-Month Post-TED ...............................................................                          200                      36            7,200                     1.15              8,280
                                                  12-Month Post-TED .............................................................                           200                      32            6,400                     1.15              7,360
                                                  Annual Post-TED .................................................................                         200                     110           22,000                     1.15             25,300

                                                        * Total ............................................................................                200   ........................        59,800     ........................         68,660
                                                     * The Total of 200 is the number of centers completing the form. The same group of 200 centers completes each of the forms.


                                                  Jason E. Bennett,                                                            Recycling of Melanogenic Proteins.’’                          Service (PHS) support for a research
                                                  Director, Division of the Executive Secretariat.                             Submitted for publication to The                              project on which Respondent’s
                                                  [FR Doc. 2016–20758 Filed 8–29–16; 8:45 am]                                  Journal of Clinical Investigations, Cell,                     participation is proposed and prior to
                                                  BILLING CODE 4165–15–P                                                       Nature Biology, Molecular Cell, and                           Respondent’s participation in any
                                                                                                                               Nature Genetics (hereafter referred to                        capacity on PHS-supported research, the
                                                                                                                               as ‘‘Manuscript 1’’)                                          institution employing him must submit
                                                  DEPARTMENT OF HEALTH AND                                                     ORI found that Respondent                                     a plan for supervision of his duties to
                                                  HUMAN SERVICES                                                             knowingly falsified and/or fabricated                           ORI for approval. The plan for
                                                                                                                             data and related images by alteration                           supervision must be designed to ensure
                                                  Office of the Secretary                                                    and/or reuse and/or relabeling of                               the scientific integrity of Respondent’s
                                                                                                                             experimental data. Specifically:                                research contribution; Respondent
                                                  Findings of Research Misconduct
                                                                                                                             • in Paper 1, Respondent falsified and/                         agreed that he will not participate in
                                                  AGENCY:      Office of the Secretary, HHS.                                   or fabricated the results in Figure 3C                        any PHS-supported research until a plan
                                                  ACTION:      Notice.                                                         by using the same gel images to                               for supervision is submitted to and
                                                                                                                               represent expression of PLDN in                               approved by ORI; Respondent agreed to
                                                  SUMMARY:    Notice is hereby given that                                      fibroblasts and melanocytes                                   maintain responsibility for compliance
                                                  the Office of Research Integrity (ORI)                                     • in Paper 2, Respondent falsified and/                         with the agreed upon supervision plan;
                                                  has taken final action in the following                                      or fabricated the results in Figure 2A                          (2) that for a period of three (3) years
                                                  case:                                                                        by erasure of a band in the blot image                        beginning on July 22, 2016, any
                                                     Andrew R. Cullinane, Ph.D., National                                      for LYST/CHD–4 that was present in                            institution employing him shall submit,
                                                  Institutes of Health: Based on                                               the original data                                             in conjunction with each application for
                                                  Respondent’s admission, an assessment                                      • in Manuscript 1, Respondent falsified                         PHS funds, or report, manuscript, or
                                                  conducted by the National Institutes of                                      and/or fabricated the results in                              abstract involving PHS-supported
                                                  Health (NIH), and analysis conducted by                                      Western blot data by reuse and                                research in which Respondent is
                                                  ORI in its oversight review, ORI found                                       relabeling, duplication, and/or                               involved, a certification to ORI that the
                                                  that Dr. Andrew R. Cullinane, former                                         manipulation in Figures 2B, 2D, 2E,                           data provided by Respondent are based
                                                  postdoctoral fellow, Medical Genetics                                        3A–C, 4C, 4E, 4G, 5B, 6A–C, 7A, 7D,                           on actual experiments or are otherwise
                                                  Branch, National Human Genome                                                7G, 7J, and Supplemental Figure 3,                            legitimately derived and that the data,
                                                  Research Institute (NHGRI), NIH,                                             and Respondent falsified and/or                               procedures, and methodology are
                                                  engaged in research misconduct in                                            fabricated the results by reuse and                           accurately reported in the application,
                                                  research supported by NHGRI, NIH.                                            relabeling of centrifuge tubes to                             report, manuscript, or abstract;
                                                     ORI found that Respondent engaged                                         represent different experiments in                              (3) to exclude himself from serving in
                                                  in research misconduct by reporting                                          Figures 1D, 7C, 7F, 7I, 7L, and                               any advisory capacity to PHS including,
                                                  falsified and/or fabricated data in the                                      Supplemental Figure 2                                         but not limited to, service on any PHS
                                                  following two (2) publications and one                                       Dr. Cullinane has entered into a                              advisory committee, board, and/or peer
                                                  (1) submitted manuscript:                                                  Voluntary Settlement Agreement with                             review committee, or as a consultant for
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                                                  • Am. J. Hum. Genet. 88(6):778–787,                                        ORI and NIH, in which he voluntarily                            a period of three (3) years, beginning on
                                                     2011 (hereafter referred to as ‘‘Paper                                  agreed:                                                         July 22, 2016; and
                                                     1’’)                                                                      (1) To have his research supervised                             (4) as a condition of the Agreement,
                                                  • Neurology 86(14):1320–1328, 2016                                         for a period of three (3) years beginning                       Respondent agreed to the retraction or
                                                     (hereafter referred to as ‘‘Paper 2’’)                                  on July 22, 2016; Respondent agreed to                          correction of:
                                                  • ‘‘RAB11FIP1, Mutated in HPS–10,                                          ensure that prior to the submission of an                       • Am. J. Hum. Genet. 88(6):778–787,
                                                     Interacts with BLOC–1 to Mitigate                                       application for U.S. Public Health                                2011


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                                                                               Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices                                                 59643

                                                  • Neurology 86(14):1320–1328, 2016                      will focus on the Diabetes and                        would constitute a clearly unwarranted
                                                  FOR FURTHER INFORMATION CONTACT:                        Neurocognition.                                       invasion of personal privacy.
                                                  Director, Office of Research Integrity,                    Any member of the public interested                  Name of Committee: National Institute on
                                                  1101 Wootton Parkway, Suite 750,                        in presenting oral comments to the                    Aging Initial Review Group, Behavior and
                                                  Rockville, MD 20852, (240) 453–8200.                    Committee should notify the contact                   Social Science of Aging Review Committee.
                                                                                                          person listed on this notice at least 10                Date: September 29–30, 2016.
                                                  Kathryn M. Partin,                                      days in advance of the meeting.                         Time: 4:00 p.m. to 2:00 p.m.
                                                  Director, Office of Research Integrity.                 Interested individuals and                              Agenda: To review and evaluate grant
                                                  [FR Doc. 2016–20834 Filed 8–29–16; 8:45 am]             representatives or organizations should               applications.
                                                  BILLING CODE 4150–31–P                                  submit a letter of intent, a brief                      Place: Doubletree Hotel Bethesda,
                                                                                                                                                                (Formerly Holiday Inn Select), 8120
                                                                                                          description of the organization                       Wisconsin Avenue, Bethesda, MD 20814.
                                                                                                          represented, and a written copy of their                Contact Person: Kimberly Firth, Ph.D.,
                                                  DEPARTMENT OF HEALTH AND                                oral presentation in advance of the                   National Institute on Aging, Gateway
                                                  HUMAN SERVICES                                          meeting. Only one representative of an                Building, 7201 Wisconsin Avenue, Suite
                                                                                                          organization will be allowed to present;              2W200, Bethesda, MD 20892, 301–402–7702,
                                                  National Institutes of Health
                                                                                                          oral comments and presentations will be               kimberly.firth@nih.gov.
                                                  Notice of Diabetes Mellitus Interagency                 limited to a maximum of 5 minutes.                      Name of Committee: National Institute on
                                                  Coordinating Committee Meeting                          Printed and electronic copies are                     Aging Initial Review Group, Clinical Aging
                                                                                                          requested for the record. In addition,                Review Committee.
                                                  SUMMARY:    The Diabetes Mellitus                       any interested person may file written                  Date: September 29–30, 2016.
                                                  Interagency Coordinating Committee                      comments with the Committee by                          Time: 4:00 p.m. to 1:00 p.m.
                                                  (DMICC) will hold a meeting on                                                                                  Agenda: To review and evaluate grant
                                                                                                          forwarding their statement to the                     applications.
                                                  September 12, 2016. The subject of the                  contact person listed on this notice. The
                                                  meeting will be the ‘‘Diabetes and                                                                              Place: Doubletree Hotel Bethesda,
                                                                                                          statement should include the name,                    (Formerly Holiday Inn Select), 8120
                                                  Neurocognition.’’ The meeting is open                   address, telephone number and when                    Wisconsin Avenue, Bethesda, MD 20814.
                                                  to the public.                                          applicable, the business or professional                Contact Person: Alicja L. Markowska,
                                                  DATES: The meeting will be held on                      affiliation of the interested person.                 Ph.D., DSC, National Institute on Aging,
                                                  September 12, 2016; from 1:00 p.m. to                   Because of time constraints for the                   National Institutes of Health, Gateway
                                                  4:30 p.m. Individuals wanting to present                meeting, oral comments will be allowed                Building 2W200, 7201 Wisconsin Avenue,
                                                  oral comments must notify the contact                   on a first-come, first-serve basis.                   Bethesda, MD 20892, 301–496–9666,
                                                  person at least 10 days before the                                                                            markowsa@nia.nih.gov.
                                                                                                             Members of the public who would
                                                  meeting date.                                           like to receive email notification about              (Catalogue of Federal Domestic Assistance
                                                  ADDRESSES: The meeting will be held in                                                                        Program Nos. 93.866, Aging Research,
                                                                                                          future DMICC meetings should register
                                                                                                                                                                National Institutes of Health, HHS)
                                                  the Democracy 2 Building at 6707                        for the listserv available on the DMICC
                                                  Democracy Blvd., Bethesda, MD, in                       Web site, www.diabetescommittee.gov.                    Dated: August 24, 2016.
                                                  Conference Room 7050.                                     Dated: August 24, 2016.
                                                                                                                                                                Melanie J. Gray,
                                                  FOR FURTHER INFORMATION CONTACT: For                                                                          Program Analyst, Office of Federal Advisory
                                                                                                          B. Tibor Roberts,
                                                  further information concerning this                                                                           Committee Policy.
                                                                                                          Executive Secretary, DMICC, Office of
                                                  meeting, see the DMICC Web site,                        Scientific Program and Policy Analysis,
                                                                                                                                                                [FR Doc. 2016–20727 Filed 8–29–16; 8:45 am]
                                                  www.diabetescommittee.gov, or contact                   National Institute of Diabetes and Digestive          BILLING CODE 4140–01–P
                                                  Dr. B. Tibor Roberts, Executive                         and Kidney Diseases, National Institutes of
                                                  Secretary of the Diabetes Mellitus                      Health.
                                                  Interagency Coordinating Committee,                     [FR Doc. 2016–20824 Filed 8–29–16; 8:45 am]           DEPARTMENT OF HEALTH AND
                                                  National Institute of Diabetes and                      BILLING CODE 4140–01–P
                                                                                                                                                                HUMAN SERVICES
                                                  Digestive and Kidney Diseases, 31
                                                  Center Drive, Building 31A, Room                                                                              National Institutes of Health
                                                  9A19, MSC 2560, Bethesda, MD 20892–                     DEPARTMENT OF HEALTH AND
                                                  2560, telephone: 301–496–6623; FAX:                                                                           National Institute of Mental Health;
                                                                                                          HUMAN SERVICES                                        Notice of Closed Meeting
                                                  301–480–6741; email: dmicc@
                                                  mail.nih.gov.                                           National Institutes of Health                           Pursuant to section 10(d) of the
                                                  SUPPLEMENTARY INFORMATION: The                                                                                Federal Advisory Committee Act, as
                                                                                                          National Institute on Aging; Notice of                amended (5 U.S.C. App.), notice is
                                                  DMICC, chaired by the National
                                                                                                          Closed Meetings                                       hereby given of the following meeting.
                                                  Institute of Diabetes and Digestive and
                                                  Kidney Diseases (NIDDK) comprising                        Pursuant to section 10(d) of the                      The meeting will be closed to the
                                                  members of the Department of Health                     Federal Advisory Committee Act, as                    public in accordance with the
                                                  and Human Services and other federal                    amended (5 U.S.C. App.), notice is                    provisions set forth in sections
                                                  agencies that support diabetes-related                  hereby given of the following meetings.               552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                  activities, facilitates cooperation,                      The meetings will be closed to the                  as amended. The grant applications and
                                                  communication, and collaboration on                     public in accordance with the                         the discussions could disclose
                                                  diabetes among government entities.                     provisions set forth in sections                      confidential trade secrets or commercial
                                                  DMICC meetings, held several times a                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            property such as patentable material,
mstockstill on DSK3G9T082PROD with NOTICES




                                                  year, provide an opportunity for                        as amended. The grant applications and                and personal information concerning
                                                  Committee members to learn about and                    the discussions could disclose                        individuals associated with the grant
                                                  discuss current and future diabetes                     confidential trade secrets or commercial              applications, the disclosure of which
                                                  programs in DMICC member                                property such as patentable material,                 would constitute a clearly unwarranted
                                                  organizations and to identify                           and personal information concerning                   invasion of personal privacy.
                                                  opportunities for collaboration. The                    individuals associated with the grant                  Name of Committee: National Institute of
                                                  September 12, 2016 DMICC meeting                        applications, the disclosure of which                 Mental Health Special Emphasis Panel.



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Document Created: 2018-02-09 11:41:53
Document Modified: 2018-02-09 11:41:53
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.
ContactDirector, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation81 FR 59642 

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