Findings of Research Misconduct, 22461-22463 [2023-07850]

Download as PDF 22461 Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of information collection Total responses Average burden per response (in hours) Total burden hours Mail/email 1 ........................................................................... Telephone ............................................................................ Web-based ........................................................................... Focus Groups ...................................................................... In-person .............................................................................. Automated 2 .......................................................................... Cognitive Testing ................................................................. 1,000 1,000 1,200 925 250 500 700 1 1 1 1 1 1 1 1,000 1,000 1,200 925 250 500 700 0.26 0.26 0.25 1.00 1.00 1.00 1.41 260 260 300 925 250 500 987 Total .............................................................................. 5,575 ........................ 5,575 ........................ 3482 1 May 2 May include telephone non-response follow-up in which case the burden will not change. include testing of database software, Computer Assisted Personal Interviewing software, or other automated technologies. HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2023–07774 Filed 4–12–23; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Findings of research misconduct have been made against Carlo Spirli, Ph.D. (Respondent), who was an Assistant Professor of Medicine, Department of Digestive Diseases, Yale University (YU). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants R01 DK079005 and P30 DK034989. The administrative actions, including debarment for a period of four (4) years, were implemented beginning on March 28, 2023, and are detailed below. FOR FURTHER INFORMATION CONTACT: Sheila Garrity, JD, MPH, MBA, Director, Office of Research Integrity, 1101 SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 Number of responses per respondent VerDate Sep<11>2014 17:56 Apr 12, 2023 Jkt 259001 Wootton Parkway, Suite 240, Rockville, MD 20852, (240) 453–8200. Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Carlo Spirli, Ph.D., Yale University: Based on the report of an investigation conducted by YU and additional analysis conducted by ORI in its oversight review, ORI found that Carlo Spirli, Ph.D., former Assistant Professor of Medicine, Department of Digestive Diseases, YU, engaged in research misconduct in research supported by PHS funds, specifically NIDDK, NIH, grants R01 DK079005 and P30 DK034989. ORI found that Respondent engaged in research misconduct by knowingly, intentionally, or recklessly falsifying and/or fabricating data included in the following four (4) published papers, two (2) presentations, and three (3) grant applications submitted for PHS funds: • Cyclic AMP/PKA-dependent Paradoxical Activation of Raf/MEK/ERK Signaling in Polycystin-2 Defective Mice Treated with Sorafenib. Hepatology. 2012 Dec;56(6):2363–74. doi: 10.1002/ hep.25872 (hereafter referred to as ‘‘Hepatology 2012a’’). • Altered Store Operated Calcium Entry Increases Cyclic 3′,5′-Adenosine Monophosphate Production and Extracellular Signal-Regulated Kinases 1 and 2 Phosphorylation in Polycystin-2Defective Cholangiocytes. Hepatology. 2012 Mar;55(3):856–68. doi: 10.1002/ hep.24723 (hereafter referred to as ‘‘Hepatology 2012b’’). • Protein Kinase A-Dependent pSer(675)-b-catenin, a Novel Signaling Defect in a Mouse Model of Congenital Hepatic Fibrosis. Hepatology. 2013 Nov;58(5):1713–23. doi:10.1002/ SUPPLEMENTARY INFORMATION: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 hep.26554 (hereafter referred to as ‘‘Hepatology 2013’’). • Posttranslational Regulation of Polycystin-2 Protein Expression as a Novel Mechanism of Cholangiocyte Reaction and Repair from Biliary Damage. Hepatology. 2015 Dec; 62(6):1828–39. doi: 10.1002/hep.28138 (hereafter referred to as ‘‘Hepatology 2015’’). Retraction in: Hepatology. 2022 Dec;76(6):1904. doi: 10.1002/hep.32595. • PKA-Dependent p-SER675-bCatenin Phosphorylation Increases Cholangiocyte Motility in Pkhd1del4/ del4 Mouse, a Model of Fibropolycystic Liver Diseases Caused by Defective Fibrocystin Function. Presented at the European Association for the Study of the Liver (EASL) (hereafter referred to as ‘‘EASL Presentation 2011’’). • Cyclic-AMP-Dependent, Rac1Mediated Nuclear Translocation Of PSer-675b-Catenin, A Novel Signaling Defect in Congenital Hepatic Fibrosis (CHF) and Caroli’s Disease (CD). Presented at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting, Boston, MA, in November 2012 (hereafter referred to as ‘‘AASLD Presentation 2011’’). • R01 DK079005–11A1, ‘‘Epithelial Angiogenic Signaling in Biliary Pathophysiology and in Polycystic Disease,’’ submitted to NIDDK, NIH, on December 13, 2018. Administratively withdrawn by the funding agency on March 1, 2021. • R01 DK090021–01 ‘‘Mechanisms of fibrosis in fibrocystin-deficiency associated cholangiopathies’’ submitted to NIDDK, NIH, on February 2, 2010. Administratively withdrawn by the funding agency on July 1, 2012. • R01 DK090021–01A1 ‘‘Mechanisms of fibrosis in fibrocystin-deficiency associated cholangiopathies’’ submitted to NIDDK, NIH, on November 11, 2010. E:\FR\FM\13APN1.SGM 13APN1 lotter on DSK11XQN23PROD with NOTICES1 22462 Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices Administratively withdrawn by the funding agency on July 1, 2015. Respondent knowingly, intentionally, or recklessly falsified and/or fabricated Western blot image data for cholangiopathies in a murine model of Congenital Hepatic Fibrosis (CHF) by reusing blot images, with or without manipulating them to conceal their similarities, and falsely relabeling them as data representing different experiments or proteins and falsifying quantitative data in associated graphs purportedly derived from those images in twenty-one (21) figures included in four (4) papers, two (2) presentations, and three (3) grant applications. In the absence of reliable image and numerical data, the figures, statistical analyses, and related text also are false. Specifically, the respondent reused Western blot images from the same source and falsely relabeled them to represent different proteins and/or experimental results in: • Hepatology 2012a: —Figure 3, representing different concentrations of sorafenib treatment in: ➢ pERK blot panel, lanes 1–2 and 3– 4 are the same ➢ pERK blot panel, lanes 2, 4, and 5 are the same —Figure 4C and Figure 6C (left), representing different concentrations of sorafenib treatment in: ➢ CC3 blot panel, lanes 1 and 2 are the same —Figure 4C, representing different concentrations of sorafenib treatment in: ➢ Actin blot panel, lanes 3–7 for wild type (WT) and lanes 8–12 for Pkd2cKO cholangiocytes are the same —Figure 5A (left), representing B-Raf kinase activity with different concentrations of sorafenib treatment in WT: ➢ ERK1/2 blot panel, lanes 1–2 and lanes 3–4 are the same —Figure 5A (right), representing and Raf-1 kinase activity with different concentrations of sorafenib treatment in WT: ➢ ERK1/2 blot panel, lanes 1–2 and lanes 3–4 are the same • Hepatology 2012b: —Figure 6A, representing thapsigargin treatment in WT and Pkd2KO cholangiocytes: ➢ ERK blot panel, lanes 1–3 WT and lanes 4–6 Pkd2KO are the same • Hepatology 2013: —Figure 1A in: ➢ pSer675-b-Cat blot panel, lanes 1– 3 for WT are a mirror image of lanes VerDate Sep<11>2014 17:56 Apr 12, 2023 Jkt 259001 4–6 for PC–KO ➢ pSer675-b-Cat blot panel, lane 1 for WT control and lane 9 for Pkhd1del4/del4, PKA inhibitor are the same —Figure 5A: ➢ Actin blot panel, lanes 1–4 for WT and lanes 6–9 for Pkhd1del4/del4 are the same • Hepatology 2015: —Figure 2A: ➢ PC2 blot panel, lane 4 for ‘‘TNFa’’ and lane 5 for ‘‘Mix’’ are the same ➢ PC2 blot panel, lane 6 for ‘‘DETA’’ and lane 7 for ‘‘Thapsi’’ are the same ➢ Actin blot panel, lane 6 for ‘‘DETA’’ and lane 7 for ‘‘Thapsi’’ are the same —Figure 4A: ➢ PC2 blot panel, lane 1 for ‘‘Ctrl’’ and lane 8 for ‘‘Mix+MG+GHX’’ are the same ➢ PC2 blot panel, lane 3 for ‘‘Mix,’’ lane 4 for ‘‘Mix+CHX,’’ and lane 5 for ‘‘MG’’ are the same —Figure 4C: ➢ NEK1 blot panel, lane 6 for ‘‘Thapsi’’ and lane 7 for ‘‘DETA’’ are the same —Figure 5 (left): ➢ PC2, blot panel, lane 1 for ‘‘Ctrl’’ and lane 2 for ‘‘MG’’ are the same ➢ PC2 blot panel, lanes 3–4 for ‘‘TNFa’’ and ‘‘TNFa+MG’’ and lanes 7–8 for ‘‘Mix,’’ and ‘‘Mix+MG’’ are the same ➢ Actin blot panel, lanes 1–4 for ‘‘Ctrl,’’ ‘‘MG,’’ ‘‘TNFa,’’ and ‘‘TNFa+MG’’ and lanes 5–8 for ‘‘INFg,’’ ‘‘INFg+MG,’’ ‘‘Mix,’’ and ‘‘Mix+MG’’ are the same —Figure 5 (right): ➢ Actin blot panel, lanes 5–6 for ‘‘INFg’’ and ‘‘INFg+MG’’ and lanes 7–8 for ‘‘Mix’’ and ‘‘Mix+MG’’ are the same —Figure 6D: ➢ LC3–II blot panel, lane 2 for ‘‘Thapsi’’ and lane 8 for ‘‘Chloroq’’ are the same —Figure 7B: ➢ PC2 blot panel, lanes 11–12, 13– 14, and 15–16 are the same representing six repeat experiments of ‘‘DDC’’ mice ➢ PC2 blot panel, lanes 5–6, 7–8, and 9–10 are the same representing six repeat experiments of ‘‘DDC+Bort’’ mice ➢ Actin blot panel, lanes 1–4 for ‘‘Ctrl,’’ lanes 5–8 for ‘‘DDC,’’ and lanes 11–14 for ‘‘DDC+Bort’’ are the same ➢ Actin blot panel, lanes 9–10 for ‘‘DDC’’ and lanes 15–16 for ‘‘DDC+Bort’’ are the same —Figure 8B: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 ➢ Actin blot panel, lanes 1–5 for ‘‘WT’’ and lanes 6–10 for Mdr2-/are the same • AASLD Presentation 2012: —Slide 7: ➢ pSer675 b-Cat blot panel, lanes 1– 3 WT are the same as pSer675 b-Cat blot panel, lanes 4–6 PC–KO in Figure 1A of Hepatology 2013 ➢ pSer675 b-Cat blot panel, lanes 4– 6 WT are the same as pSer675 b-Cat blot panel, lanes 7–9 Pkhd1del4/del4 in Figure 1A of Hepatology 2013 ➢ b-Cat blot panel, lanes 1–3 WT are the same as b-Cat blot panel, lanes 4–6 Pkhd1del4/del4 in Figure 1A of Hepatology 2013 ➢ b-Cat blot panel, lanes 4–6 WT are the same as b-Cat blot panel, lanes 7–9 Pkhd1del4/del4 in Figure 1A of Hepatology 2013 • R01 DK090021–01 and R01 DK090021–01A1: —Figure 8 (and Slide 9 of EASL Presentation 2011): ➢ p675-b-Cat blot panel, lanes 8 and 9 are spliced in over the bands from unrelated sources ➢ H3 Hyst blot, lane 8 is spliced in over the bands from unrelated sources • R01 DK079005–11A1: —Figure 12A: ➢ VEGFR2 blot panel, lanes 5 and 6– 8 are spliced in from unrelated sources —Figure 12B: ➢ VEGFR2 blot panel, lanes 7 and 8 are spliced in from unrelated sources Dr. Spirli entered into a Voluntary Exclusion Agreement (Agreement) and voluntarily agreed to the following: (1) Respondent will exclude himself voluntarily for a period of four (4) years beginning on March 28, 2023 (the ‘‘Exclusion Period’’) from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement or procurement transactions referred to as ‘‘covered transactions’’ in 2 CFR parts 180 and 376 (collectively the ‘‘Debarment Regulations’’). (2) During the Exclusion Period, Respondent will exclude himself voluntarily from serving in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee. (3) Respondent will request that the following papers be corrected or retracted: • Hepatology 2012;56:2363–74. doi: 10.1002/hep.25872 E:\FR\FM\13APN1.SGM 13APN1 Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices • Hepatology 2012;55(3):856–68. doi:10.1002/hep.24723 • Hepatology 2013;58(5):1713–23. doi: 10.1002/hep.26554 Respondent will copy ORI and the Research Integrity Officer at YU on the correspondence with the journal. Dated: April 10, 2023. Sheila Garrity, Director, Office of Research Integrity, Office of the Assistant Secretary for Health. [FR Doc. 2023–07850 Filed 4–12–23; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Global Affairs: Stakeholder Listening Session for the G7 Health Ministers’ Meeting Notice of public listening session; request for comments. ACTION: The listening session will be held on Thursday, May 4, 2023, from 12:00 p.m. to 2:00 p.m., Eastern Daylight Time. Place: The session will be held virtually, with online and dial-in information shared with registered participants. Status: This meeting is open to the public but requires RSVP to OGA.RSVP1@hhs.gov by April 28, 2023. See RSVP section below for details. SUPPLEMENTARY INFORMATION: Purpose: The U.S. Department of Health and Human Services (HHS), with support from relevant health-related U.S. Government offices, is charged with leading the U.S. delegation to the Group of 7 (G7) Health Ministers’ Meeting and will convene an informal Stakeholder Listening Session. The Stakeholder Listening Session is designed to seek input from stakeholders to help inform and prepare for U.S. government engagement in the Health Ministers’ Meeting. The G7 is an informal grouping of Canada, France, Germany, Italy, Japan, the United States, and the United Kingdom, and it also includes participation by the European Commission. Each year, a different member country serves as the presidency of the group and hosts the meetings. The presidency proposes the group’s priorities for the year and hosts discussions to work towards consensus positions and actions on those priorities. This year’s G7 presidency is Japan, which will be hosting the Health Ministers’ Meeting on May 13 and 14, 2023. Matters to be Discussed: The listening session will cover priority areas lotter on DSK11XQN23PROD with NOTICES1 DATES: VerDate Sep<11>2014 17:56 Apr 12, 2023 Jkt 259001 expected to be addressed at the G7 Health Ministers’ Meeting. Provisional agenda items for the Health Ministers’ Meeting include to: 1. Develop and strengthen global health architecture for public health emergencies; 2. Contribute to achieving more resilient, equitable and sustainable universal health coverage through strengthening health systems; and 3. Promote health innovation to address various health challenges. More information on the 2023 G7 Health Ministers’ Meeting can be found at: https://www.mhlw.go.jp/stf/ seisakunitsuite/bunya/hokabunya/ kokusai/g8/g7health2023_en.html. 1. Participation is welcome from all stakeholder communities. RSVP: Persons seeking to speak at the listening session must register by Friday, April 28, 2023. Persons seeking to attend the listening session in a listen-only capacity must register by Tuesday, May 2, 2023. Registrants must include their full name, email address, and organization, if any, and indicate whether they are registering as a listen-only attendee or as a speaker participant to OGA.RSVP1@ hhs.gov. Requests to participate as a speaker must include all of the following: 1. The name and email address of the person desiring to participate 2. The organization(s) that person represents, if any 3. Identification of the primary topic of interest Other Information: Written comments should be emailed to OGA.RSVP1@ hhs.gov with the subject line ‘‘Written Comment Re: Stakeholder Listening Session for the G7 Health Ministers Meeting’’ by Friday, May 5, 2023. We look forward to your comments on the G7 Health Ministers’ Meeting. Susan Kim, Chief of Staff, Office of Global Affairs. [FR Doc. 2023–07811 Filed 4–12–23; 8:45 am] BILLING CODE 4150–38–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Global Affairs: Stakeholder Listening Session on Amendments to the International Health Regulations (2005) Notice of public listening session; request for comments. ACTION: The listening session will be held on Tuesday, June 20th, 2023, from DATES: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 22463 12:00 p.m. to 2:00 p.m., Eastern Daylight Time. Place: The session will be held virtually, with online and dial-in information shared with registered participants. Status: This meeting is open to the public but requires RSVP to OGA.RSVP1@hhs.gov by Friday, June 9, 2023. See RSVP section below for details. SUPPLEMENTARY INFORMATION: Purpose: The U.S. Department of Health and Human Services (HHS) is charged with leading U.S. participation in the Working Group on the Amendments to the International Health Regulations (2005) and will convene a Stakeholder Listening Session. The World Health Assembly (WHA) originally adopted the International Health Regulations (IHR) in 1969. The regulations were amended multiple times, resulting in the current IHR (2005). The purpose of IHR (2005) is to prevent, protect against, control, and provide public health response to the international spread of disease. In May 2021, Member States set up a Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) with the intent of strengthening WHO’s capacities and ability to support Member States in the prevention and response of public health emergencies. The WGPR produced a report with key findings and recommendations that included amending the IHR. The United States submitted a package of targeted amendments to the IHR for consideration. These amendments seek to improve early warnings and alerts, transparency, and accountability in a manner that does not compromise national security or sovereignty. Other countries have also submitted proposals that the United States seek feedback from stakeholders on the proposed amendments. The Stakeholder Listening Session is designed to seek input from stakeholders and subject-matter experts on these proposals and to help inform and prepare the U.S. government for engagement with the Working Group on the Amendments to the International Health Regulations (2005). Matters to be Discussed: The listening session will discuss potential amendments to the IHR (2005). Topics will include those amendments currently under consideration by the Working Group. An Article-by-Article Compilation of Proposed Amendments to the International Health Regulations (2005) can be found here: https:// apps.who.int/gb/wgihr/pdf_files/wgihr1/ WGIHR_Compilation-en.pdf. E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22461-22463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07850]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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

SUMMARY: Findings of research misconduct have been made against Carlo 
Spirli, Ph.D. (Respondent), who was an Assistant Professor of Medicine, 
Department of Digestive Diseases, Yale University (YU). Respondent 
engaged in research misconduct in research supported by U.S. Public 
Health Service (PHS) funds, specifically National Institute of Diabetes 
and Digestive and Kidney Diseases (NIDDK), National Institutes of 
Health (NIH), grants R01 DK079005 and P30 DK034989. The administrative 
actions, including debarment for a period of four (4) years, were 
implemented beginning on March 28, 2023, and are detailed below.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of 
Research Integrity (ORI) has taken final action in the following case:
    Carlo Spirli, Ph.D., Yale University: Based on the report of an 
investigation conducted by YU and additional analysis conducted by ORI 
in its oversight review, ORI found that Carlo Spirli, Ph.D., former 
Assistant Professor of Medicine, Department of Digestive Diseases, YU, 
engaged in research misconduct in research supported by PHS funds, 
specifically NIDDK, NIH, grants R01 DK079005 and P30 DK034989.
    ORI found that Respondent engaged in research misconduct by 
knowingly, intentionally, or recklessly falsifying and/or fabricating 
data included in the following four (4) published papers, two (2) 
presentations, and three (3) grant applications submitted for PHS 
funds:
     Cyclic AMP/PKA-dependent Paradoxical Activation of Raf/
MEK/ERK Signaling in Polycystin-2 Defective Mice Treated with 
Sorafenib. Hepatology. 2012 Dec;56(6):2363-74. doi: 10.1002/hep.25872 
(hereafter referred to as ``Hepatology 2012a'').
     Altered Store Operated Calcium Entry Increases Cyclic 
3',5'-Adenosine Monophosphate Production and Extracellular Signal-
Regulated Kinases 1 and 2 Phosphorylation in Polycystin-2-Defective 
Cholangiocytes. Hepatology. 2012 Mar;55(3):856-68. doi: 10.1002/
hep.24723 (hereafter referred to as ``Hepatology 2012b'').
     Protein Kinase A-Dependent pSer(675)-[beta]-catenin, a 
Novel Signaling Defect in a Mouse Model of Congenital Hepatic Fibrosis. 
Hepatology. 2013 Nov;58(5):1713-23. doi:10.1002/hep.26554 (hereafter 
referred to as ``Hepatology 2013'').
     Posttranslational Regulation of Polycystin-2 Protein 
Expression as a Novel Mechanism of Cholangiocyte Reaction and Repair 
from Biliary Damage. Hepatology. 2015 Dec; 62(6):1828-39. doi: 10.1002/
hep.28138 (hereafter referred to as ``Hepatology 2015''). Retraction 
in: Hepatology. 2022 Dec;76(6):1904. doi: 10.1002/hep.32595.
     PKA-Dependent p-SER675-b-Catenin Phosphorylation Increases 
Cholangiocyte Motility in Pkhd1del4/del4 Mouse, a Model of 
Fibropolycystic Liver Diseases Caused by Defective Fibrocystin 
Function. Presented at the European Association for the Study of the 
Liver (EASL) (hereafter referred to as ``EASL Presentation 2011'').
     Cyclic-AMP-Dependent, Rac1-Mediated Nuclear Translocation 
Of P-Ser-675[beta]-Catenin, A Novel Signaling Defect in Congenital 
Hepatic Fibrosis (CHF) and Caroli's Disease (CD). Presented at the 
American Association for the Study of Liver Diseases (AASLD) Annual 
Meeting, Boston, MA, in November 2012 (hereafter referred to as ``AASLD 
Presentation 2011'').
     R01 DK079005-11A1, ``Epithelial Angiogenic Signaling in 
Biliary Pathophysiology and in Polycystic Disease,'' submitted to 
NIDDK, NIH, on December 13, 2018. Administratively withdrawn by the 
funding agency on March 1, 2021.
     R01 DK090021-01 ``Mechanisms of fibrosis in fibrocystin-
deficiency associated cholangiopathies'' submitted to NIDDK, NIH, on 
February 2, 2010. Administratively withdrawn by the funding agency on 
July 1, 2012.
     R01 DK090021-01A1 ``Mechanisms of fibrosis in fibrocystin-
deficiency associated cholangiopathies'' submitted to NIDDK, NIH, on 
November 11, 2010.

[[Page 22462]]

Administratively withdrawn by the funding agency on July 1, 2015.
    Respondent knowingly, intentionally, or recklessly falsified and/or 
fabricated Western blot image data for cholangiopathies in a murine 
model of Congenital Hepatic Fibrosis (CHF) by reusing blot images, with 
or without manipulating them to conceal their similarities, and falsely 
relabeling them as data representing different experiments or proteins 
and falsifying quantitative data in associated graphs purportedly 
derived from those images in twenty-one (21) figures included in four 
(4) papers, two (2) presentations, and three (3) grant applications. In 
the absence of reliable image and numerical data, the figures, 
statistical analyses, and related text also are false.
    Specifically, the respondent reused Western blot images from the 
same source and falsely relabeled them to represent different proteins 
and/or experimental results in:

     Hepatology 2012a:

--Figure 3, representing different concentrations of sorafenib 
treatment in:
    [rtarr8] pERK blot panel, lanes 1-2 and 3-4 are the same
    [rtarr8] pERK blot panel, lanes 2, 4, and 5 are the same
--Figure 4C and Figure 6C (left), representing different concentrations 
of sorafenib treatment in:
    [rtarr8] CC3 blot panel, lanes 1 and 2 are the same
--Figure 4C, representing different concentrations of sorafenib 
treatment in:
    [rtarr8] Actin blot panel, lanes 3-7 for wild type (WT) and lanes 
8-12 for Pkd2cKO cholangiocytes are the same
--Figure 5A (left), representing B-Raf kinase activity with different 
concentrations of sorafenib treatment in WT:
    [rtarr8] ERK1/2 blot panel, lanes 1-2 and lanes 3-4 are the same
--Figure 5A (right), representing and Raf-1 kinase activity with 
different concentrations of sorafenib treatment in WT:
    [rtarr8] ERK1/2 blot panel, lanes 1-2 and lanes 3-4 are the same
     Hepatology 2012b:

--Figure 6A, representing thapsigargin treatment in WT and Pkd2KO 
cholangiocytes:
    [rtarr8] ERK blot panel, lanes 1-3 WT and lanes 4-6 Pkd2KO are the 
same
     Hepatology 2013:

--Figure 1A in:
    [rtarr8] pSer\675\-[beta]-Cat blot panel, lanes 1-3 for WT are a 
mirror image of lanes 4-6 for PC-KO
    [rtarr8] pSer\675\-[beta]-Cat blot panel, lane 1 for WT control and 
lane 9 for Pkhd1del4/del4, PKA inhibitor are the same
--Figure 5A:
    [rtarr8] Actin blot panel, lanes 1-4 for WT and lanes 6-9 for 
Pkhd1del4/del4 are the same
     Hepatology 2015:

--Figure 2A:
    [rtarr8] PC2 blot panel, lane 4 for ``TNF[alpha]'' and lane 5 for 
``Mix'' are the same
    [rtarr8] PC2 blot panel, lane 6 for ``DETA'' and lane 7 for 
``Thapsi'' are the same
    [rtarr8] Actin blot panel, lane 6 for ``DETA'' and lane 7 for 
``Thapsi'' are the same
--Figure 4A:
    [rtarr8] PC2 blot panel, lane 1 for ``Ctrl'' and lane 8 for 
``Mix+MG+GHX'' are the same
    [rtarr8] PC2 blot panel, lane 3 for ``Mix,'' lane 4 for 
``Mix+CHX,'' and lane 5 for ``MG'' are the same
--Figure 4C:
    [rtarr8] NEK1 blot panel, lane 6 for ``Thapsi'' and lane 7 for 
``DETA'' are the same
--Figure 5 (left):
    [rtarr8] PC2, blot panel, lane 1 for ``Ctrl'' and lane 2 for ``MG'' 
are the same
    [rtarr8] PC2 blot panel, lanes 3-4 for ``TNF[alpha]'' and 
``TNF[alpha]+MG'' and lanes 7-8 for ``Mix,'' and ``Mix+MG'' are the 
same
    [rtarr8] Actin blot panel, lanes 1-4 for ``Ctrl,'' ``MG,'' 
``TNF[alpha],'' and ``TNF[alpha]+MG'' and lanes 5-8 for ``INF[gamma],'' 
``INF[gamma]+MG,'' ``Mix,'' and ``Mix+MG'' are the same
--Figure 5 (right):
    [rtarr8] Actin blot panel, lanes 5-6 for ``INF[gamma]'' and 
``INF[gamma]+MG'' and lanes 7-8 for ``Mix'' and ``Mix+MG'' are the same
--Figure 6D:
    [rtarr8] LC3-II blot panel, lane 2 for ``Thapsi'' and lane 8 for 
``Chloroq'' are the same
--Figure 7B:
    [rtarr8] PC2 blot panel, lanes 11-12, 13-14, and 15-16 are the same 
representing six repeat experiments of ``DDC'' mice
    [rtarr8] PC2 blot panel, lanes 5-6, 7-8, and 9-10 are the same 
representing six repeat experiments of ``DDC+Bort'' mice
    [rtarr8] Actin blot panel, lanes 1-4 for ``Ctrl,'' lanes 5-8 for 
``DDC,'' and lanes 11-14 for ``DDC+Bort'' are the same
    [rtarr8] Actin blot panel, lanes 9-10 for ``DDC'' and lanes 15-16 
for ``DDC+Bort'' are the same
--Figure 8B:
    [rtarr8] Actin blot panel, lanes 1-5 for ``WT'' and lanes 6-10 for 
Mdr2-/- are the same

 AASLD Presentation 2012:

--Slide 7:
    [rtarr8] pSer\675\ [beta]-Cat blot panel, lanes 1-3 WT are the same 
as pSer\675\ [beta]-Cat blot panel, lanes 4-6 PC-KO in Figure 1A of 
Hepatology 2013
    [rtarr8] pSer\675\ [beta]-Cat blot panel, lanes 4-6 WT are the same 
as pSer\675\ [beta]-Cat blot panel, lanes 7-9 Pkhd1del4/del4 
in Figure 1A of Hepatology 2013
    [rtarr8] [beta]-Cat blot panel, lanes 1-3 WT are the same as 
[beta]-Cat blot panel, lanes 4-6 Pkhd1del4/del4 in Figure 1A 
of Hepatology 2013
    [rtarr8] [beta]-Cat blot panel, lanes 4-6 WT are the same as 
[beta]-Cat blot panel, lanes 7-9 Pkhd1del4/del4 in Figure 1A 
of Hepatology 2013

 R01 DK090021-01 and R01 DK090021-01A1:

--Figure 8 (and Slide 9 of EASL Presentation 2011):
    [rtarr8] p\675\-[beta]-Cat blot panel, lanes 8 and 9 are spliced in 
over the bands from unrelated sources
    [rtarr8] H3 Hyst blot, lane 8 is spliced in over the bands from 
unrelated sources

 R01 DK079005-11A1:

--Figure 12A:
    [rtarr8] VEGFR2 blot panel, lanes 5 and 6-8 are spliced in from 
unrelated sources
--Figure 12B:
    [rtarr8] VEGFR2 blot panel, lanes 7 and 8 are spliced in from 
unrelated sources

    Dr. Spirli entered into a Voluntary Exclusion Agreement (Agreement) 
and voluntarily agreed to the following:
    (1) Respondent will exclude himself voluntarily for a period of 
four (4) years beginning on March 28, 2023 (the ``Exclusion Period'') 
from any contracting or subcontracting with any agency of the United 
States Government and from eligibility for or involvement in 
nonprocurement or procurement transactions referred to as ``covered 
transactions'' in 2 CFR parts 180 and 376 (collectively the ``Debarment 
Regulations'').
    (2) During the Exclusion Period, Respondent will exclude himself 
voluntarily from serving in any advisory or consultant capacity to PHS 
including, but not limited to, service on any PHS advisory committee, 
board, and/or peer review committee.
    (3) Respondent will request that the following papers be corrected 
or retracted:

 Hepatology 2012;56:2363-74. doi: 10.1002/hep.25872

[[Page 22463]]

 Hepatology 2012;55(3):856-68. doi:10.1002/hep.24723
 Hepatology 2013;58(5):1713-23. doi: 10.1002/hep.26554

    Respondent will copy ORI and the Research Integrity Officer at YU 
on the correspondence with the journal.

    Dated: April 10, 2023.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2023-07850 Filed 4-12-23; 8:45 am]
BILLING CODE 4150-31-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.