83 FR 22497 - Findings of Research Misconduct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 83, Issue 94 (May 15, 2018)
Office of the Secretary
Federal Register Volume 83, Issue 94 (May 15, 2018)
| Page Range | 22497-22498 | |
| FR Document | 2018-10310 |
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)] [Notices] [Pages 22497-22498] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10310] ----------------------------------------------------------------------- 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 on the part of Gareth John, Ph.D., Professor, Department of Neurology, Icahn School of Medicine at Mount Sinai (ISMMS). Dr. John engaged in research misconduct in research supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grants R01 NS056074 and R01 NS062703. The administrative actions, including one (1) year of supervision, were implemented beginning on April 26, 2018, and are detailed below. FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, 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: Gareth John, Ph.D., Icahn School of Medicine at Mount Sinai: Based on Respondent's admission, the report of an inquiry and investigation conducted by ISMMS, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Gareth John, Professor, Department of Neurology, ISMMS, engaged in research misconduct in research supported by NINDS, NIH, grants R01 NS056074 and R01 NS062703. [[Page 22498]] ORI found that Respondent engaged in research misconduct by knowingly and intentionally falsifying data reported in Development 141(12):2414-28, 2014 Jun (hereafter referred to as ``Development 2014''). In addition to making an admission, Respondent cooperated fully with ISMMS and ORI and has expressed remorse for his actions. Specifically, ORI found that Respondent:used the p-GSK3[alpha]/[beta] double bands in Figure S3B of Development 2014, removed the lower set of bands, reordered the remaining bands and used those bands to represent the actin control in an experiment comparing the impact of Tgf[beta]1 and ActB individually and in combination in primary oligodendrocyte progenitors (OLPs) and the oligodendrocyte-derived Oli-Neu cell line. used the densitometry readings from the falsified actin bands in Figure S3B of Development 2014 to compare the density of A+T, Tgf[beta]1, ActB, and Veh relative to the false actin signal in Figure S3C-J, creating eight false graphs. falsified the bands representing Myelin basic protein (Mbp) in Figure 3C of Development 2014 by cutting and pasting the bands onto a blank background and used those false bands to create a graph showing the density of Mbp in the presence and absence of ActB, Tgf[beta]1, and Bmp4. As a result of this admission, Respondent has notified Development that corrections to figures in the paper, but not to the text, including the conclusions in Development 2014 are required. Dr. John entered into a Voluntary Settlement Agreement and voluntarily agreed, beginning on April 26, 2018: (1) To have his research supervised for a period of one (1) year; 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 agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that for one (1) year, 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) if no supervisory plan is provided to ORI, to provide certification to ORI at the conclusion of the supervision period that he has not engaged in, applied for, or had his name included on any application, proposal, or other request for PHS funds without prior notification to ORI; (4) 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 one (1) year; and (5) to follow up with the journal editor regarding his previous request to correct the following paper to ensure that the corrections are made: Development 141(12):2414-28, 2014 Jun. Wanda K. Jones, Interim Director, Office of Research Integrity. [FR Doc. 2018-10310 Filed 5-14-18; 8:45 am] BILLING CODE 4150-31-P
![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22497
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learn about possible modifications Findings of Research Misconduct
and written submissions submitted to
before coming to the meeting. the Docket (see ADDRESSES) on or before AGENCY: Office of the Secretary, HHS.
SUPPLEMENTARY INFORMATION: June 5, 2018, will be provided to the ACTION: Notice.
Agenda: The particular matter for this subcommittee. Oral presentations from
meeting will be review and discussion the public will be scheduled between SUMMARY: Findings of research
of a list of molecular targets for which approximately 10:25 a.m. and 10:45 misconduct have been made on the part
evidence and/or biologic rationale exist a.m., 1:40 p.m. and 2 p.m., and 3:40 of Gareth John, Ph.D., Professor,
to determine their potential relevance to p.m. and 4:30 p.m. Those individuals Department of Neurology, Icahn School
the growth or progression of one or interested in making formal oral of Medicine at Mount Sinai (ISMMS).
more pediatric cancers and a list of presentations should notify the contact Dr. John engaged in research
those targets deemed unlikely to be person and submit a brief statement of misconduct in research supported by
associated with the growth or the general nature of the evidence or National Institute of Neurological
progression of pediatric tumors. These arguments they wish to present, the Disorders and Stroke (NINDS), National
lists are expected to fulfill the statutory names and addresses of proposed Institutes of Health (NIH), grants R01
obligation of the Food and Drug participants, and an indication of the NS056074 and R01 NS062703. The
Administration Reauthorization Act approximate time requested to make administrative actions, including one (1)
(FDARA) and provide some guidance to their presentation on or before May 25, year of supervision, were implemented
industry in planning for initial Pediatric 2018. Time allotted for each beginning on April 26, 2018, and are
Study Plan submissions for new drug presentation may be limited. If the detailed below.
and/or biologic products in number of registrants requesting to FOR FURTHER INFORMATION CONTACT:
development for cancer in accordance speak is greater than can be reasonably Wanda K. Jones, Dr.P.H., Interim
with the amended provisions of the accommodated during the scheduled Director, Office of Research Integrity,
Pediatric Research Equity Act. The open public hearing session, FDA may 1101 Wootton Parkway, Suite 750,
committee will review and discuss conduct a lottery to determine the Rockville, MD 20852, (240) 453–8200.
considerations other than scientific speakers for the scheduled open public SUPPLEMENTARY INFORMATION: Notice is
relevance that FDA will include in hearing session. The contact person will hereby given that the Office of Research
decision making with respect to the notify interested persons regarding their Integrity (ORI) has taken final action in
need and timing of pediatric evaluation request to speak by May 29, 2018. the following case:
of specific new drug and biologic Persons attending FDA’s advisory Gareth John, Ph.D., Icahn School of
products. The committee will discuss committee meetings are advised that Medicine at Mount Sinai: Based on
possible criteria and mechanisms for the FDA is not responsible for providing Respondent’s admission, the report of
prioritization by sponsors and the access to electrical outlets. an inquiry and investigation conducted
clinical investigator community of For press inquiries, please contact the by ISMMS, and additional analysis
daltland on DSKBBV9HB2PROD with NOTICES
select targeted new agents for pediatric Office of Media Affairs at fdaoma@ conducted by ORI in its oversight
evaluation especially in the setting of fda.hhs.gov or 301–796–4540. review, ORI found that Dr. Gareth John,
multiple same in class agents. FDA welcomes the attendance of the Professor, Department of Neurology,
Preliminary discussion will focus on public at its advisory committee ISMMS, engaged in research
approaches to coordination and meetings and will make every effort to misconduct in research supported by
collaboration for pediatric clinical accommodate persons with disabilities. NINDS, NIH, grants R01 NS056074 and
investigations of new agents that might If you require accommodations due to a R01 NS062703.
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![22498 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
ORI found that Respondent engaged (2) that for one (1) year, any Name of Committee: Microbiology,
in research misconduct by knowingly institution employing him shall submit, Infectious Diseases and AIDS Initial Review
and intentionally falsifying data in conjunction with each application for Group Microbiology and Infectious Diseases
PHS funds, or report, manuscript, or Research Committee.
reported in Development 141(12):2414–
Date: June 7–8, 2018.
28, 2014 Jun (hereafter referred to as abstract involving PHS-supported Time: 9:30 a.m. to 4:30 p.m.
‘‘Development 2014’’). research in which Respondent is Agenda: To review and evaluate grant
In addition to making an admission, involved, a certification to ORI that the applications.
Respondent cooperated fully with data provided by Respondent are based Place: National Institutes of Health, 5601
ISMMS and ORI and has expressed on actual experiments or are otherwise Fishers Lane, Rockville, MD 20892
remorse for his actions. legitimately derived and that the data, (Telephone Conference Call).
Specifically, ORI found that procedures, and methodology are Contact Person: Frank S. De Silva, Ph.D.,
Respondent: accurately reported in the application, Scientific Review Officer, Scientific Review
• used the p-GSK3a/b double bands report, manuscript, or abstract;
Program, Division of Extramural Activities,
in Figure S3B of Development 2014, Room #3E72A, National Institutes of Health/
(3) if no supervisory plan is provided NIAID, 5601 Fishers Lane, MSC 9834,
removed the lower set of bands, to ORI, to provide certification to ORI at Bethesda, MD 20892934, (240) 669–5023,
reordered the remaining bands and used the conclusion of the supervision period fdesilva@niaid.nih.gov.
those bands to represent the actin that he has not engaged in, applied for, (Catalogue of Federal Domestic Assistance
control in an experiment comparing the or had his name included on any Program Nos. 93.855, Allergy, Immunology,
impact of Tgfb1 and ActB individually application, proposal, or other request and Transplantation Research; 93.856,
and in combination in primary for PHS funds without prior notification Microbiology and Infectious Diseases
oligodendrocyte progenitors (OLPs) and to ORI; Research, National Institutes of Health, HHS)
the oligodendrocyte-derived Oli-Neu (4) to exclude himself voluntarily Dated: May 10, 2018.
cell line. from serving in any advisory capacity to Natasha M. Copeland,
• used the densitometry readings PHS including, but not limited to,
from the falsified actin bands in Figure Program Analyst, Office of Federal Advisory
service on any PHS advisory committee, Committee Policy.
S3B of Development 2014 to compare board, and/or peer review committee, or [FR Doc. 2018–10316 Filed 5–14–18; 8:45 am]
the density of A+T, Tgfb1, ActB, and as a consultant for a period of one (1)
Veh relative to the false actin signal in BILLING CODE 4140–01–P
year; and
Figure S3C–J, creating eight false (5) to follow up with the journal
graphs. editor regarding his previous request to
• falsified the bands representing DEPARTMENT OF HEALTH AND
correct the following paper to ensure HUMAN SERVICES
Myelin basic protein (Mbp) in Figure 3C that the corrections are made:
of Development 2014 by cutting and • Development 141(12):2414–28, National Institutes of Health
pasting the bands onto a blank 2014 Jun.
background and used those false bands National Institute of Biomedical
to create a graph showing the density of Wanda K. Jones,
Imaging and Bioengineering; Notice of
Mbp in the presence and absence of Interim Director, Office of Research Integrity.
Closed Meeting
ActB, Tgfb1, and Bmp4. [FR Doc. 2018–10310 Filed 5–14–18; 8:45 am]
As a result of this admission, BILLING CODE 4150–31–P Pursuant to section 10(d) of the
Respondent has notified Development Federal Advisory Committee Act, as
that corrections to figures in the paper, amended, notice is hereby given of the
but not to the text, including the DEPARTMENT OF HEALTH AND meeting of the National Institute of
conclusions in Development 2014 are HUMAN SERVICES Biomedical Imaging and Bioengineering
required. Special Emphasis Panel.
Dr. John entered into a Voluntary National Institutes of Health The meeting will be closed to the
Settlement Agreement and voluntarily public in accordance with the
National Institute of Allergy and provisions set forth in sections
agreed, beginning on April 26, 2018:
(1) To have his research supervised Infectious Diseases; Notice of Closed 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
for a period of one (1) year; Respondent Meeting as amended. The grant applications and
agreed that prior to submission of an Pursuant to section 10(d) of the the discussions could disclose
application for U.S. Public Health Federal Advisory Committee Act, as confidential trade secrets or commercial
Service (PHS) support for a research amended, notice is hereby given of a property such as patentable material,
project on which the Respondent’s meeting of Microbiology, Infectious and personal information concerning
participation is proposed and prior to Diseases and AIDS Initial Review Group individuals associated with the grant
Respondent’s participation in any Microbiology and Infectious Diseases applications, the disclosure of which
capacity on PHS-supported research, Research Committee. would constitute a clearly unwarranted
Respondent shall ensure that a plan for The meeting will be closed to the invasion of personal privacy.
supervision of Respondent’s duties is public in accordance with the Name of Committee: National Institute of
submitted to ORI for approval; the provisions set forth in sections Biomedical Imaging and Bioengineering
supervision plan must be designed to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Special Emphasis Panel; P41 BTRC Review
ensure the scientific integrity of as amended. The grant applications and (2018/10).
Respondent’s research contribution; the discussions could disclose Date: July 5–7, 2018.
daltland on DSKBBV9HB2PROD with NOTICES
Respondent agreed that he shall not confidential trade secrets or commercial Time: 6:00 p.m. to 1:00 p.m.
participate in any PHS-supported property such as patentable material, Agenda: To review and evaluate grant
applications and/or proposals.
research until such a supervision plan is and personal information concerning Place: Courtyard by Marriott New York
submitted to and approved by ORI; individuals associated with the grant Manhattan/Upper ES, 410 East 92nd Street,
Respondent agreed to maintain applications, the disclosure of which New York, NY 10128.
responsibility for compliance with the would constitute a clearly unwarranted Contact Person: Manana Sukhareva, Ph.D.,
agreed upon supervision plan; invasion of personal privacy. Scientific Review Officer, National Institute
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Document Created: 2018-05-15 00:34:13
Document Modified: 2018-05-15 00:34:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Wanda K. Jones, Dr.P.H., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200. | |
| FR Citation | 83 FR 22497 |
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