[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62803-62807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19779]


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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.

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SUMMARY: Findings of research misconduct have been made against Andrew 
Dannenberg, M.D. (Respondent), who was a Professor of Medicine, 
Department of Medicine, Weill Cornell Medical College (WCMC). 
Respondent engaged in research misconduct in research supported by U.S. 
Public Health Service (PHS) funds, specifically National Cancer 
Institute (NCI), National Institutes of Health (NIH), grants P01 
CA077839, P01 CA106451, R01 CA108773, R01 CA154481, T32 CA009685, R25 
CA105012, and N01 CN43302, National Institute on Deafness and Other 
Communication Disorders (NIDCD), NIH, grant T32 DC000027, and National 
Center for Advancing Translational Sciences (NCATS), NIH, grant UL1 
TR000457. The administrative actions, including supervision for a 
period of seven (7) years, were implemented beginning on August 14, 
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:
    Andrew Dannenberg, M.D., Weill Cornell Medical College (WCMC): 
Based on the report of an investigation conducted by WCMC and 
additional analysis conducted by ORI in its oversight review, ORI found 
that Andrew Dannenberg, former Professor of Medicine, Department of 
Medicine, WCMC, engaged in research misconduct in research supported by 
PHS funds, specifically NCI, NIH, grants P01 CA077839, P01 CA106451, 
R01 CA108773, R01 CA154481, T32 CA009685, R25 CA105012, and N01 
CN43302, NIDCD, NIH, grant T32 DC000027, and NCATS, NIH, grant UL1 
TR000457.
    ORI found that Respondent engaged in research misconduct by 
recklessly reporting falsified and/or fabricated data in the following 
twelve (12) published papers:
     Increased levels of COX-2 and prostaglandin E2 contribute 
to elevated aromatase expression in inflamed breast tissue of obese 
women. Cancer Discov. 2012 Apr;2(4):356-65. doi: 10.1158/2159-8290.CD-
11-0241 (hereafter referred to as ``Cancer Discov. 2012''). Retraction 
in: Cancer Discov. 2021 May;11(5):1306. doi: 10.1158/2159-8290.CD-21-
0224.
     EP2 and EP4 receptors regulate aromatase expression in 
human

[[Page 62804]]

adipocytes and breast cancer cells. Evidence of a BRCA1 and p300 
exchange. J Biol Chem. 2008 Feb 8;283(6):3433-44. doi: 10.1074/
jbc.M705409200 (hereafter referred to as ``J Biol Chem. 2008''). 
Retraction in: J Biol Chem. 2020 Jan 3; 295(1):295. doi: 10.1074/
jbc.W119.012140.
     HDAC6 modulates Hsp90 chaperone activity and regulates 
activation of aryl hydrocarbon receptor signaling. J Biol Chem. 2009 
Mar 20; 284(12):7436-45. doi: 10.1074/jbc.M808999200 (hereafter 
referred to as ``J Biol Chem. 2009''). Retraction in: J Biol Chem. 2020 
Jan 3; 295(1):297. doi: 10.1074/jbc.W119.012142.
     p53 protein regulates Hsp90 ATPase activity and thereby 
Wnt signaling by modulating Aha1 expression. J Biol Chem. 2014 Mar 
7;289(10):6513-25. doi: 10.1074/jbc.M113.532523 (hereafter referred to 
as ``J Biol Chem. 2014''). Retraction in: J Biol Chem. 2020 Jan 3; 
295(1):289. doi: 10.1074/jbc.W119.012134.
     Hsp90 and PKM2 drive the expression of aromatase in Li-
Fraumeni syndrome breast adipose stromal cells. J Biol Chem. 2016 Jul 
29;291(31):16011-23. doi: 10.1074/jbc.M115.698902 (hereafter referred 
to as ``J Biol Chem. 2016''). Retraction in: J Biol Chem. 2020 Jan 3; 
295(1):290. doi: 10.1074/jbc.W119.012135.
     Heat shock protein 90 inhibitors suppress aryl hydrocarbon 
receptor-mediated activation of CYP1A1 and CYP1B1 transcription and DNA 
adduct formation. Cancer Prev Res (Phila). 2008 Nov;1(6):485-93. doi: 
10.1158/1940-6207.CAPR-08-0149 (hereafter referred to as ``Cancer Prev 
Res. 2008''). Retraction in: Cancer Prev Res (Phila). 2022 Jun 
2;15(6):415. doi: 10.1158/1940-6207.CAPR-22-0200.
     Obesity is associated with inflammation and elevated 
aromatase expression in the mouse mammary gland. Cancer Prev Res 
(Phila). 2011 Mar;4(3):329-46. doi: 10.1158/1940-6207.CAPR-10-0381 
(hereafter referred to as ``Cancer Prev Res. 2011''). Retraction in: 
Cancer Prev Res (Phila). 2022 Jun 2; 15(6):413. doi: 10.1158/1940-
6207.CAPR-22-0202.
     Carnosol, a constituent of Zyflamend, inhibits aryl 
hydrocarbon receptor-mediated activation of CYP1A1 and CYP1B1 
transcription and mutagenesis. Cancer Prev Res (Phila). 2012 
Apr;5(4):593-602. doi: 10.1158/1940-6207.CAPR-12-0002 (hereafter 
referred to as ``Cancer Prev Res. 2012a''). Retraction in: Cancer Prev 
Res (Phila). 2022 Jun 2;15(6):412. doi: 10.1158/1940-6207.CAPR-22-0203.
     Pioglitazone, a PPAR[gamma] agonist, suppresses CYP19 
transcription: evidence for involvement of 15-hydroxyprostaglandin 
dehydrogenase and BRCA1. Cancer Prev Res (Phila). 2012 Oct;5(10):1183-
94. doi: 10.1158/1940-6207.CAPR-12-0201 (hereafter referred to as 
``Cancer Prev Res. 2012b''). Retraction in: Cancer Prev Res (Phila). 
2022 Jun 2;15(6):411. doi: 10.1158/1940-6207.CAPR-22-0204.
     Caloric restriction reverses obesity-induced mammary gland 
inflammation in mice. Cancer Prev Res (Phila). 2013 Apr;6(4):282-9. 
doi: 10.1158/1940-6207.CAPR-12-0467 (hereafter referred to as ``Cancer 
Prev Res. 2013''). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2; 
15(6):410. doi: 10.1158/1940-6207.CAPR-22-0205.
     p53 modulates Hsp90 ATPase activity and regulates aryl 
hydrocarbon receptor signaling. Cancer Prev Res (Phila). 2014 
Jun;7(6):596-606. doi: 10.1158/1940-6207.CAPR-14-0051 (hereafter 
referred to as ``Cancer Prev Res. 2014''). Retraction in: Cancer Prev 
Res (Phila). 2022 Jun 2;15(6):408. doi: 10.1158/1940-6207.CAPR-22-0207.
     Id1 deficiency protects against tumor formation in 
Apc(Min/+) mice but not in a mouse model of colitis-associated colon 
cancer. Cancer Prev Res (Phila). 2015 Apr;8(4):303-11. doi: 10.1158/
1940-6207.CAPR-14-0411 (hereafter referred to as ``Cancer Prev Res. 
2015''). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2;15(6):407. 
doi: 10.1158/1940-6207.CAPR-22-0208.
    Respondent recklessly reported falsified and/or fabricated Western 
blot image data that were reused, with or without manipulation to 
conceal their similarities, and falsely relabeled as data representing 
different experiments or proteins in sixty (60) figure panels included 
in twelve (12) published papers. In the absence of reliable image and 
numerical data, the figures, statistical analyses, and related text 
also are false.
    Specifically, Respondent reported Western blot images that were 
reused from the same source and falsely relabeled to represent 
different proteins and/or experimental results in:

 Cancer Discov. 2012:
--Figure 2B, [beta]-Actin panel, representing [beta]-Actin expression 
in inflamed breast tissue with different levels of inflammation:
    [ssquf] All lanes are duplicated by reusing a same source band with 
manipulation
--Figure 4C, representing the expression of progesterone receptor (PR) 
and [beta]-Actin in inflamed breast tissue with different levels of 
inflammation:
    [ssquf] PR panel: Lanes 1, 2, and 14-16 are duplicated by reusing a 
same source band with manipulation; lanes 3, 6-9, 13, and 17 are 
duplicated by reusing a same source band with manipulation
    [ssquf] [beta]-Actin panel: All lanes are duplicated by reusing a 
same source band with manipulation
--Figure 5H, [beta]-Actin panel, representing [beta]-Actin expression 
in macrophages with different treatments:
    [ssquf] Lane 2 and lane 4 are identical
 J Biol Chem. 2008:
--Figure 2B, lanes 1-3, Aromatase panel, representing aromatase 
expression in adipocytes treated with PGE1 alcohol, and Figure 2E, 
lanes 2-4, Aromatase panel, representing aromatase expression in 
adipocytes treated with PGE2 with or without ONO, are 
duplicated by reusing the same source images with manipulation
--Figure 3B, 18S rRNA panel, representing 18S rRNA expression in 
adipocytes with different treatments:
    [ssquf] Lanes 2 and 6 are identical
    [ssquf] Lanes 3 and 7 are identical
--Figure 5A, 18S rRNA panel, representing 18S rRNA expression in 
adipocytes treated with different doses of PGE2:
    [ssquf] Lanes 1 and 5 are identical
    [ssquf] Lanes 2 and 6 are identical
--Figure 5B, [beta]-actin panel, representing [beta]-actin expression 
in adipocytes treated with different doses of PGE2:
    [ssquf] Lanes 1, 3, and 4 are identical
--Figure 6D, BRCA1 and Aromatase panels, representing expression of 
both BRCA1 and aromatase in SKBR3 cells treated with different doses of 
PGE1 alcohol:
    [ssquf] Lanes 3-4, BRCA1 panel and lanes 1-2, Aromatase panel are 
duplicated by reusing the same source images with manipulation
--Figure 5A, BRCA1 panel, representing BRCA1 expression in adipocytes 
treated with different doses of PGE2:
    [ssquf] Lanes 3-6 are falsified and/or fabricated
--Figure 5C, 18S rRNA panel, representing 18S rRNA expression in 
adipocytes treated with different doses of butaprost:
    [ssquf] Entire 18S rRNA panel is falsified and/or fabricated
--Figure 5E:
    [ssquf] Lane 4, BRCA1 panel and lane 1, 18S rRNA panel are 
identical
--Figures 6C, 6D, 6E, and 6F:
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 1, BRCA1 panel, representing BRCA1 
expression in control sample without treatment of butaprost

[[Page 62805]]

    [rtarr8] Figure 6C, lane 3, Aromatase panel, representing aromatase 
expression with 0.25 [mu]M butaprost treatment
    [rtarr8] Figure 6D, lane 1, BRCA1 panel, representing BRCA1 
expression in control sample without treatment of PGE1 alcohol
    [rtarr8] Figure 6F, lane 1, BRCA1 panel, representing BRCA1 
expression in control sample without treatment of PGE2 and 
ONO
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.10 [mu]M butaprost
    [rtarr8] Figure 6D, lane 3, Aromatase panel, representing aromatase 
expression in sample treated with 0.25 [mu]M PGE1 alcohol
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.25 [mu]M butaprost
    [rtarr8]Figure 6D, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.25 [mu]M PGE1 alcohol
    [rtarr8]Figure 6D, lane 2, Aromatase panel, representing aromatase 
expression in sample treated with 0.10 [mu]M PGE1 alcohol
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8]Figure 6C, lane 4, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.50 [mu]M butaprost
    [rtarr8]Figure 6C, lane 1, Aromatase panel, representing aromatase 
expression in control sample without treatment of butaprost
    [rtarr8]Figure 6D, lane 1, Aromatase panel, representing aromatase 
expression in control sample without treatment of PGE1 alcohol
    [rtarr8]Figure 6E, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 without AH6809
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8]Figure 6C, lane 2, Aromatase panel, representing aromatase 
expression in sample treated with 0.10 [mu]M butaprost
    [rtarr8]Figure 6E, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 and 25 [mu]M AH6809
    [rtarr8]Figure 6F, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 but without ONO
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8]Figure 6C, lane 4, Aromatase panel, representing aromatase 
expression in sample treated with 0.50 [mu]M butaprost
    [rtarr8]Figure 6D, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.10 [mu]M PGE1 alcohol
    [rtarr8]Figure 6E, lane 4, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 and 50 [mu]M AH6809
    [rtarr8]Figure 6F, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 and 0.10 [mu]M ONO
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8]Figure 6D, 18S rRNA panel, representing 18S rRNA expression 
in samples treated with different doses of PGE1 alcohol
    [rtarr8]Figure 6F, 18S rRNA panel, representing 18S rRNA expression 
in samples treated with different doses of PGE2 and ONO
 J Biol Chem. 2009:
--Figures 2A and 2B, [beta]-actin panels, representing [beta]-actin 
expression in KYSE450 cells and MSK-Leuk1 cells, respectively:
    [ssquf] The two panels are identical
--Figure 3B, representing protein expression at two different time 
points:
    [ssquf] Column 4, 1-hour panel, and column 2, 3-hour panel, are 
duplicated by reusing the same source images with resizing
--Figure 6H, representing expression of different proteins with 
different treatments:
    [ssquf] Column 1, Control group and column 3, Control siRNA group 
are identical
--Figure 6I, representing expression of different proteins with 
different treatments:
    [ssquf] Lanes 2 and 5, column 1 are identical
    [ssquf] Lane 3, column 1 and lane 5, column 2 are identical
--Figure 8G, Input panel, representing input protein expression in A549 
cells with different treatments:
    [ssquf] Lanes 2 and 3 are identical
--Figure 9B, Input panel, representing input protein expression in 
different samples:
    [ssquf] Lanes 2 and 3 are identical
--Figures 8E and 9D:
    [ssquf] Images used in the following figures are duplicated by 
reusing a same source band with resizing:
    [rtarr8]Figure 8E, lane 2, AhR panel, representing AhR expression 
in sample treated with B[a]P
    [rtarr8]Figure 9D, lane 3, [beta]-actin panel, representing [beta]-
actin expression in K/R sample treated with TS
--Figure 9D, [beta]-actin panel, representing [beta]-actin expression 
under different experimental conditions:
    [ssquf] Lane 1 is falsified and/or fabricated
--Figure 9C, Input panel, representing input protein expression in K/A 
sample:
    [ssquf] Lane 5 is falsified and/or fabricated
--Figure S1A, p23 panel, representing p23 expression in MSK-Leuk1 cells 
and A549 cells:
    [ssquf] Lanes 1 and 2 are identical
--Figure S1C, XAP-2 panel, representing XAP-2 expression in control and 
sample treated with HDAC6 KD:
    [ssquf] Lanes 1 and 2 are identical
--Figure S1B, representing expression of different proteins in MSK-
Leuk1 cells with different treatments:
    [ssquf] Lanes 3 and 4, Hsp90 panel are identical
    [ssquf] Lanes 1 and 2, AhR panel are identical
    [ssquf] Lanes 1 and 2, [beta]-actin panel are identical
    [ssquf] Lanes 3 and 4, [beta]-actin panel are identical
--Figure S1E, representing expression of different proteins in MSK-
Leuk1 cells with different treatments:
    [ssquf] Lane 1, Hsp90 panel, and lanes 1 and 2, HDAC6 panel, are 
identical
    [ssquf] Lane 3, Hsp90 panel, and lane 3, XAP-2 panel, are identical
--Figure S2, representing expression of different proteins in MSK-Leuk1 
cells with different treatments:
    [ssquf] Last lane, IB AcK panel, and lanes 3 and 5, IB HSP90 panel, 
are duplicated with resizing
    [ssquf] Lane 4, IB AcK panel, and lanes 1, 4, and 6, IB HSP90 
panel, are duplicated with resizing
    [ssquf] Lane 4, IB AcK panel, is falsified and/or fabricated
 J Biol Chem. 2014:
--Figure 1D, representing expression of different proteins treated with 
control or p53 siRNA:
    [ssquf] Lane 1, p53 panel, and lanes 1 and 2, [beta]-actin panel, 
are duplicated by reusing a same source band with manipulation
--Figure 2B, [beta]-actin panel, representing [beta]-actin expression 
in HCT-15 cells treated with different doses of CP-31398:
    [ssquf] Lane 1 and lane 5 are identical
    [ssquf] Lane 2 and lane 6 are identical
--Figure 4K, p23 panel, representing p23 expression in samples treated

[[Page 62806]]

with different doses of CP-31398 in HCT-15 cells:
    [ssquf] Lanes 2-4 are identical
--Figures 4H, 4I, and 4L, [beta]-actin panels, representing [beta]-
actin expression under different experimental conditions:
    [ssquf] [beta]-actin panels in Figures 4H and 4I, and lanes 3-4, 
[beta]-actin panel in Figure 4L are duplicated by reusing the same 
source images with manipulation
--Figures 4J, 4K, and 4L, representing expression of HOP (Figure 4J) 
and [beta]-actin (Figures 4K and 4L) under different experimental 
conditions:
    [ssquf] Lanes 1-2, HOP panel in Figure 4J, lanes 3-4, [beta]-actin 
panel in Figure 4K, and lanes 1-2, [beta]-actin panel in Figure 4L are 
duplicated by reusing the same source images with manipulation
--Figures 5A and 5B, [beta]-actin panels, representing [beta]-actin 
expression in both HCT-15 cells and EB-1 cells, are identical
--Figure 5H, c-Myc panel and Naked-1 panel, representing expression of 
c-Myc and Naked-1 in EB-1 cells, are duplicated with resizing
--Figures 10A and 10B, representing [beta]-actin (Figure 10A) and Aha1 
(Figure 10B) expression:
    [ssquf] Lanes 2-3, [beta]-actin panel in Figure 10A and lanes 2-3, 
Aha1 panel in Figure 10B are duplicated with resizing
 J Biol Chem. 2016:
--Figures 1C and 7A, [beta]-actin panels, representing [beta]-actin 
expression in different cells:
    [ssquf] Lanes 1-2, [beta]-actin panel in Figure 1C and lanes 2-3, 
[beta]-actin panel in Figure 7A are duplicated by reusing the same 
source images with manipulation
--Figure 5B, representing expression of different proteins with 
different treatments:
    [ssquf] Lane 6, PKM2 panel, and lane 5, Hsp90 panel, are identical
--Figure 5A, representing expression of different proteins with 
different treatments:
    [ssquf] Lane 2, HIF-1[alpha] panel, and lane 1, [beta]-actin panel, 
are identical
 Cancer Prev Res. 2008:
--Figure 2B, [beta]-actin panel, representing [beta]-actin expression 
in different cells with different treatments:
    [ssquf] Left middle [beta]-actin panel and right middle [beta]-
actin panel are duplicated by reusing the same source images with 
manipulation
--Figures 3A and 3B, [beta]-actin panels, representing [beta]-actin 
expression in different cells with different treatments:
    [ssquf] Left top [beta]-actin panel in Figure 3A and left top 
[beta]-actin panel in Figure 3B are identical
    [ssquf] Right top [beta]-actin panel in Figure 3A and left bottom 
[beta]-actin panel in Figure 3B are duplicated by reusing the same 
source images with manipulation
    [ssquf] Right bottom [beta]-actin panel in Figure 3A and right 
bottom [beta]-actin panel in Figure 3B are identical
 Cancer Prev Res. 2011:
--Figure 3A, representing expression of different proteins with 
different treatments:
    [ssquf] Lane 1, aP2 panel, is falsified and/or fabricated
    [ssquf] Lanes 3 and 5, aP2 panel, and lanes 1-6, 18S rRNA panel, 
are identical
 Cancer Prev Res. 2012a:
--Figure 4A, representing input expression treated with different doses 
of Zyflamend with or without 17-AAG:
    [ssquf] Lanes 1-5 are identical
    [ssquf] Lanes 6-7 are identical
--Figure 4B, representing input expression treated with different doses 
of carnosol with or without 17-AAG:
    [ssquf] Lanes 1-5 are identical
 Cancer Prev Res. 2012b:
--Figure 2, representing expression of different proteins under 
different experimental conditions:
    [ssquf] Lane 1, 15-PGDH panel in Figure 2B and lanes 3-4, [beta]-
Actin panel in Figure 2E are duplicated by reusing a same source band 
with manipulation
    [ssquf] Lane 2, [beta]-Actin panel in Figure 2B and lane 1, Snail 
panel in Figure 2E are duplicated by reusing a same source band with 
manipulation
    [ssquf] Lane 3, Snail panel in Figure 2G and lane 1, 15-PGDH panel 
in Figure 2H are duplicated by reusing a same source band with 
manipulation
    [ssquf] Lanes 1 and 2, [beta]-Actin panel in Figure 2H are 
duplicated by reusing a same source band with manipulation
    [ssquf] Lanes 1-3, [beta]-Actin panel in Figure 2J and lanes 1-2, 
[beta]-Actin panel in Figure 2K are duplicated by reusing a same source 
band with manipulation
--Figure 4E, [beta]-Actin panel, representing [beta]-actin expression 
in control and pioglitazone samples:
    [ssquf] Lanes 1 and 2 are identical
 Cancer Prev Res. 2013:
--Figure 3, representing binding of nuclear protein from mammary glands 
of mice with different treatments:
    [ssquf] Lanes 7-9 (first three empty lanes are counted also) and 
lanes 13-15 are identical
 Cancer Prev Res. 2014:
--Figures 5A and 5C, representing expression of different proteins with 
different treatments:
    [ssquf] Lanes 2-3, CYP1A1 panel, and lanes 2-3, CYP1B1 panel, in 
Figure 5A and lane 3, CYP1B1 panel, in Figure 5C are duplicated by 
reusing a same source band with manipulation
--Figure 5B, [beta]-actin panel, representing [beta]-actin expression 
in different cells with different treatments:
    [ssquf] Lanes 2-4 are identical
--Figure 5D, [beta]-actin panel, representing [beta]-actin expression 
in different cells with different treatments:
    [ssquf] Lanes 1-4 are duplicated by reusing a same source band with 
manipulation
 Cancer Prev Res. 2015:
--Figure 3A, [beta]-actin panel, representing [beta]-actin expression 
in DLD-1 treated with different doses of PGE2:
    [ssquf] Lanes 1, 3, and 5 are identical
    [ssquf] Lanes 2 and 4 are identical

    Respondent entered into a Voluntary Settlement Agreement 
(Agreement) and voluntarily agreed to the following:
    (1) Respondent will have his research supervised for a period of 
seven (7) years beginning on August 14, 2023 (the ``Supervision 
Period''). Prior to the submission of an application for PHS support 
for a research project on which Respondent's participation is proposed 
and prior to Respondent's participation in any capacity in PHS-
supported research, Respondent will submit a plan for supervision of 
Respondent's duties to ORI for approval. The supervision plan must be 
designed to ensure the integrity of Respondent's research. Respondent 
will not participate in any PHS-supported research until such a 
supervision plan is approved by ORI. Respondent will comply with the 
agreed-upon supervision plan.
    (2) The requirements for Respondent's supervision plan are as 
follows:
    i. A committee of 2 senior faculty members at the institution who 
are familiar with Respondent's field of research, but not including 
Respondent's supervisor or collaborators, will provide oversight and 
guidance for a period of seven (7) years from the effective date of the 
Agreement. The committee will review primary data from Respondent's 
laboratory on a quarterly basis and submit a report to ORI at six (6) 
month intervals setting forth the committee meeting dates and 
Respondent's compliance with appropriate research standards and 
confirming the integrity of Respondent's research.
    ii. The committee will conduct an advance review of each 
application for

[[Page 62807]]

PHS funds, or report, manuscript, or abstract involving PHS-supported 
research in which Respondent is involved. The review will include a 
discussion with Respondent of the primary data represented in those 
documents and will include a certification to ORI that the data 
presented in the proposed application, report, manuscript, or abstract 
are supported by the research record.
    (3) During the Supervision Period, Respondent will ensure that any 
institution employing him submits, 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 and not plagiarized 
in the application, report, manuscript, or abstract.
    (4) If no supervision plan is provided to ORI, Respondent will 
provide certification to ORI at the conclusion of the Supervision 
Period that his participation was not proposed on a research project 
for which an application for PHS support was submitted and that he has 
not participated in any capacity in PHS-supported research.
    (5) During the Supervision 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.

    Dated: September 8, 2023.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2023-19779 Filed 9-12-23; 8:45 am]
BILLING CODE 4150-31-P