Findings of Research Misconduct, 56076-56077 [2014-22192]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES 56076 Federal Register / Vol. 79, No. 181 / Thursday, September 18, 2014 / Notices glucosamine 3–O-sulfotransferase 2 genes as a biomarker in colorectal cancer.’’ Anticancer Res. 30(12):4811– 8, 2010 Dec (hereafter referred to as ‘‘AR 2010’’); Retraction in: Anticancer Res. 32(11):5138, 2012 Nov. Respondent falsified data representing glyceraldehyde 3-phosphate dehydrogenase (GAPDH) loading controls and methylated/unmethylated polymerase chain reaction (PCR) in reverse transcription-PCR (RT–PCR) gel panels. Specifically, ORI found by a preponderance of the evidence that Respondent engaged in research misconduct by knowingly, intentionally, and recklessly falsely reporting the results of RT–PCR experiments by: 1. Reusing and relabeling an image and claiming it represents different experiments of human tumor cell lines subjected to different treatments; specifically, an identical image was used to represent the: (a) GAPDH RT–PCR panels of several lymphoma, leukemia, multiple myeloma, and colorectal cancer cell lines in CCR 2004, Figures 1A and 1B, IJC 2005, Figure 1A, IJC 2006, Figures 1A and 2A, and AR 2010, Figure 1A (b) GAPDH RT–PCR panels of the lymphoma cell lines BC–1 and Raji in CCR 2004, Figure 1B, lanes 1–3, and the colorectal cancer cell lines HCT116 and COLO201 in AR 2010, Figure 1C, lanes 4–6 (c) unmethylated form of p16 (p16UM) controls in the methylationspecific PCR (MSP) panels for the leukemia (Le) and multiple myeloma (MM) samples in CCR 2004, Figure 2 (d) p16UM MSP panels for the lymphoma (Ly) and Le samples in CCR 2004, Figure 2, and the unmethylated (UM) bands MSP panel for the colorectal cancer (CRC) cell line in IJC 2005, Figure 5. 2. Manipulating an image and claiming it represents a gel with contiguous lanes; specifically, the RT– PCR products in the lanes of gels were cropped, spliced, and pasted together to form a single image for the MSP panels in IJC 2006, Figure 3. Dr. Takahashi has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of three (3) years, beginning on August 26, 2014: (1) To have his research supervised; Respondent agrees that prior to the 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 VerDate Sep<11>2014 17:27 Sep 17, 2014 Jkt 232001 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; Respondent agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported 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; and (3) 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 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. 2014–22191 Filed 9–17–14; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Makoto Suzuki, M.D., University of Texas Southwestern Medical Center: Based on the report of an investigation conducted by the University of Texas Southwestern Medical Center (UT Southwestern) and analysis conducted by ORI in its oversight review, ORI found that Dr. Makoto Suzuki, currently a Professor in the Department of Thoracic Surgery, Kumamoto University Hospital, Kumamoto, Japan, and formerly a Visiting Scientist in the SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Hamon Center for Therapeutic Oncology Research, UT Southwestern, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants P50 CA070907 and U01 CA084971. ORI found that Respondent knowingly, intentionally, and recklessly falsified data reported in six (6) publications: • Suzuki, M., Hao, C., Takahashi, T., Shigematsu, H., Shivapurkar, N., Sathyanarayana, U.G., Iizasa, T., Fujisawa, T., Hiroshima, K., & Gazdar, A.F. ‘‘Aberrant methylation of SPARC in human lung cancers.’’ Br J Cancer 92(5):942–8, 2005 Mar 14 (hereafter referred to as ‘‘BJC 2005–1’’); Retraction in: Br J Cancer 108(3):744, 2013 Feb 19 • Suzuki, M., Shigematsu, H., Shames, D.S., Sunaga, N., Takahashi, T., Shivapurkar, N., Iizasa, T., Frankel, E.P., Minna, J.D., Fujisawa, T., & Gazdar, A.F. ‘‘DNA methylation associated inactivation of TGFbetarelated genes DRM/Gremlin, RUNX3, and HPP1 in human cancers.’’ Br J Cancer 93(9):1029–37, 2005 Oct 31 (hereafter referred to as ‘‘BJC 2005– 2’’); Retraction in: Br J Cancer 109(12)3132, 2013 Dec 10 • Suzuki, M., Shigematsu, H., Takahashi, T., Shivapurkar, N., Sathyanarayana, U.G., Iizasa, T., Fujisawa, T., & Gazdar, A.F. ‘‘Aberrant methylation of Reprimo in lung cancer.’’ Lung Cancer 47(3):309– 14; 2005 Mar (hereafter referred to as ‘‘LC 2005’’); Retraction in: Lung Cancer 85(2):337, 2014 August • Suzuki, M., Toyooka, S., Shivapurkar, N., Shigematsu, H., Miyajima, K., Takahashi, T., Stastny, V., Zern, A.L., Fujisawa, T., Pass, H.I., Carbone, M., & Gazdar, A.F. ‘‘Aberrant methylation profile of human malignant mesotheliomas and its relationship to SV40 infection.’’ Oncogene 24(7):1302–8, 2005 Feb 10 (hereafter referred to as ‘‘ONC 2005’’); Retraction in: Oncogene 33(21):2814, 2014 May 22 • Suzuki, M., Shigematsu, H., Shivapurkar, N., Reddy, J., Miyajima, K., Takahashi, T., Gazdar, A.F., & Frenkel, E.P. ‘‘Methylation of apoptosis related genes in the pathogenesis and prognosis of prostate cancer.’’ Cancer Lett. 242(2):222–30, 2006 Oct 28 (hereafter referred to as ‘‘CL 2006’’) • Suzuki, M., Shigematsu, H., Shames, D.S., Sunaga, N., Takahashi, T., Shivapurkar, N., Iizasa, T., Minna, J.D., Fujisawa, T., & Gazdar, A.F. ‘‘Methylation and gene silencing of E:\FR\FM\18SEN1.SGM 18SEN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 181 / Thursday, September 18, 2014 / Notices the Ras-related GTPase gene in lung and breast cancers.’’ Ann Surg Oncol. 14(4):1397–404, 2007 Apr (hereafter referred to as ‘‘ASO 2007’’). Respondent falsified data representing glyceraldehyde 3-phosphate dehydrogenase (GAPDH) loading controls and methylated/unmethylated polymerase chain reaction (PCR) in reverse transcription-PCR (RT–PCR) gel panels. Specifically, ORI found by a preponderance of the evidence that Respondent engaged in research misconduct by knowingly, intentionally, and recklessly falsely reporting the results of RT–PCR experiments by: 1. Reusing and relabeling an image and claiming it represents different experiments of human tumor cell lines subjected to different treatments; specifically, an identical image was used to represent the: (a) GAPDH RT–PCR panels in BJC 2005–01, Figure 1A, lanes 4–12, and Figure 1C, lanes 4–12 (b) GAPDH RT–PCR panels in BJC 2005–2, Figures 1A and 1B, and ASO 2007, Figures 1A and 1B (c) unmethylated form of p16 (p16U) RT–PCR panel in CL 2006, Figure 1, lanes 3–10, positive (P) and negative (N) controls, and the p16 U RT–PCR panel in ONC 2005, Figure 2A. 2. Manipulating an image and claiming it represents a gel with contiguous lanes; specifically, the RT– PCR products in the lanes of gels were cropped, spliced, and pasted together to form a single image for the: (a) GAPDH RT–PCR panels in LC 2005, Figures 1A and 1B (b) methylated form of Decoy receptor 2 (DcR2 M) methylation-specific PCR (MSP) panel in CL 2006, Figure 1 (c) methylated form of small Rasrelated GTPase (RRAD M) MSP panel in ASO 2007, Figure 3B. Dr. Suzuki has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of three (3) years, beginning on August 26, 2014: (1) To have his research supervised; Respondent agrees that prior to the 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; Respondent VerDate Sep<11>2014 17:27 Sep 17, 2014 Jkt 232001 agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported 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; and (3) 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 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. 2014–22192 Filed 9–17–14; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of public Webcast. AGENCY: The HHS Centers for Disease Control and Prevention’s Division of Select Agents and Toxins (DSAT) and the USDA Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) are jointly charged with the oversight of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the Webcast is to provide guidance related to the Federal Select SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 9990 56077 Agent Program for interested individuals. The Webcast will be held on Friday, November 14, 2014 from 10 a.m. to 4 p.m. EST. All who wish to join the Webcast must register by October 24, 2014. Registration instructions can be found on the Web site https:// www.selectagents.gov. DATES: The Webcast will be broadcast from the Centers for Disease Control and Prevention’s facility, 1600 Clifton Road, Atlanta, GA 30333. This will only be produced as a Webcast, therefore no accommodations will be provided for in-person participation. ADDRESSES: FOR FURTHER INFORMATION CONTACT: CDC: Ms. Diane Martin, Division of Select Agents and Toxins, Office of Public Health Preparedness and Response, CDC, 1600 Clifton Road MS A–46, Atlanta, GA 30333; phone: 404–718–2000; email: lrsat@cdc.gov. APHIS: Dr. Keith Wiggins, APHIS Agriculture Select Agent Services, 4700 River Road, Unit 2, Riverdale, MD 20737; phone: 301–851–3300 (option 3); email: AgSAS@ aphis.usda.gov. The public Webcast is an opportunity for the affected community (i.e., registered entity responsible officials, alternate responsible officials, and entity owners) and other interested individuals to obtain specific regulatory guidance and information concerning biosafety, security and incident response issues related to the Federal Select Agent Program. Representatives from the Federal Select Agent Program will be present during the Webcast to address questions and concerns from the Web participants. Individuals who want to participate in the Webcast must complete their registration online by October 24, 2014. The registration instructions are located on this Web site: https:// www.selectagents.gov. SUPPLEMENTARY INFORMATION: Dated: September 15, 2014. Ron A. Otten, Acting Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2014–22253 Filed 9–17–14; 8:45 am] BILLING CODE 4163–18–P E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Notices]
[Pages 56076-56077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22192]


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

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:
    Makoto Suzuki, M.D., University of Texas Southwestern Medical 
Center: Based on the report of an investigation conducted by the 
University of Texas Southwestern Medical Center (UT Southwestern) and 
analysis conducted by ORI in its oversight review, ORI found that Dr. 
Makoto Suzuki, currently a Professor in the Department of Thoracic 
Surgery, Kumamoto University Hospital, Kumamoto, Japan, and formerly a 
Visiting Scientist in the Hamon Center for Therapeutic Oncology 
Research, UT Southwestern, engaged in research misconduct in research 
supported by National Cancer Institute (NCI), National Institutes of 
Health (NIH), grants P50 CA070907 and U01 CA084971.
    ORI found that Respondent knowingly, intentionally, and recklessly 
falsified data reported in six (6) publications:

 Suzuki, M., Hao, C., Takahashi, T., Shigematsu, H., 
Shivapurkar, N., Sathyanarayana, U.G., Iizasa, T., Fujisawa, T., 
Hiroshima, K., & Gazdar, A.F. ``Aberrant methylation of SPARC in human 
lung cancers.'' Br J Cancer 92(5):942-8, 2005 Mar 14 (hereafter 
referred to as ``BJC 2005-1''); Retraction in: Br J Cancer 108(3):744, 
2013 Feb 19
 Suzuki, M., Shigematsu, H., Shames, D.S., Sunaga, N., 
Takahashi, T., Shivapurkar, N., Iizasa, T., Frankel, E.P., Minna, J.D., 
Fujisawa, T., & Gazdar, A.F. ``DNA methylation associated inactivation 
of TGFbeta-related genes DRM/Gremlin, RUNX3, and HPP1 in human 
cancers.'' Br J Cancer 93(9):1029-37, 2005 Oct 31 (hereafter referred 
to as ``BJC 2005-2''); Retraction in: Br J Cancer 109(12)3132, 2013 Dec 
10
 Suzuki, M., Shigematsu, H., Takahashi, T., Shivapurkar, N., 
Sathyanarayana, U.G., Iizasa, T., Fujisawa, T., & Gazdar, A.F. 
``Aberrant methylation of Reprimo in lung cancer.'' Lung Cancer 
47(3):309-14; 2005 Mar (hereafter referred to as ``LC 2005''); 
Retraction in: Lung Cancer 85(2):337, 2014 August
 Suzuki, M., Toyooka, S., Shivapurkar, N., Shigematsu, H., 
Miyajima, K., Takahashi, T., Stastny, V., Zern, A.L., Fujisawa, T., 
Pass, H.I., Carbone, M., & Gazdar, A.F. ``Aberrant methylation profile 
of human malignant mesotheliomas and its relationship to SV40 
infection.'' Oncogene 24(7):1302-8, 2005 Feb 10 (hereafter referred to 
as ``ONC 2005''); Retraction in: Oncogene 33(21):2814, 2014 May 22
 Suzuki, M., Shigematsu, H., Shivapurkar, N., Reddy, J., 
Miyajima, K., Takahashi, T., Gazdar, A.F., & Frenkel, E.P. 
``Methylation of apoptosis related genes in the pathogenesis and 
prognosis of prostate cancer.'' Cancer Lett. 242(2):222-30, 2006 Oct 28 
(hereafter referred to as ``CL 2006'')
 Suzuki, M., Shigematsu, H., Shames, D.S., Sunaga, N., 
Takahashi, T., Shivapurkar, N., Iizasa, T., Minna, J.D., Fujisawa, T., 
& Gazdar, A.F. ``Methylation and gene silencing of

[[Page 56077]]

the Ras-related GTPase gene in lung and breast cancers.'' Ann Surg 
Oncol. 14(4):1397-404, 2007 Apr (hereafter referred to as ``ASO 
2007'').

    Respondent falsified data representing glyceraldehyde 3-phosphate 
dehydrogenase (GAPDH) loading controls and methylated/unmethylated 
polymerase chain reaction (PCR) in reverse transcription-PCR (RT-PCR) 
gel panels.
    Specifically, ORI found by a preponderance of the evidence that 
Respondent engaged in research misconduct by knowingly, intentionally, 
and recklessly falsely reporting the results of RT-PCR experiments by:
    1. Reusing and relabeling an image and claiming it represents 
different experiments of human tumor cell lines subjected to different 
treatments; specifically, an identical image was used to represent the:
    (a) GAPDH RT-PCR panels in BJC 2005-01, Figure 1A, lanes 4-12, and 
Figure 1C, lanes 4-12
    (b) GAPDH RT-PCR panels in BJC 2005-2, Figures 1A and 1B, and ASO 
2007, Figures 1A and 1B
    (c) unmethylated form of p16 (p16U) RT-PCR panel in CL 2006, Figure 
1, lanes 3-10, positive (P) and negative (N) controls, and the p16 U 
RT-PCR panel in ONC 2005, Figure 2A.
    2. Manipulating an image and claiming it represents a gel with 
contiguous lanes; specifically, the RT-PCR products in the lanes of 
gels were cropped, spliced, and pasted together to form a single image 
for the:
    (a) GAPDH RT-PCR panels in LC 2005, Figures 1A and 1B
    (b) methylated form of Decoy receptor 2 (DcR2 M) methylation-
specific PCR (MSP) panel in CL 2006, Figure 1
    (c) methylated form of small Ras-related GTPase (RRAD M) MSP panel 
in ASO 2007, Figure 3B.
    Dr. Suzuki has entered into a Voluntary Settlement Agreement 
(Agreement) and has voluntarily agreed for a period of three (3) years, 
beginning on August 26, 2014:
    (1) To have his research supervised; Respondent agrees that prior 
to the 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; Respondent agrees that 
he shall not participate in any PHS-supported research until such a 
supervision plan is submitted to and approved by ORI; Respondent agrees 
to maintain responsibility for compliance with the agreed upon 
supervision plan;
    (2) that 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; and
    (3) 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 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. 2014-22192 Filed 9-17-14; 8:45 am]
BILLING CODE 4150-28-P
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