Findings of Research Misconduct, 73007-73009 [2022-25866]
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Lauren K. Roth,
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[FR Doc. 2022–25813 Filed 11–25–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
PO 00000
Office of the Secretary, HHS;
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ACTION:
73007
Notice.
Findings of research
misconduct have been made against
Douglas D. Taylor, Ph.D. (Respondent),
former Professor and Vice Chair for
Research, Department of Obstetrics &
Gynecology, University of Louisville
School of Medicine (UL). 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 R41 CA139802 and R21
CA098166. The administrative actions,
including debarment for a period of
three (3) years, were implemented
beginning on October 17, 2022, and are
detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Acting
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:
Douglas D. Taylor, Ph.D., University
of Louisville School of Medicine: Based
on the evidence and findings of
investigations conducted by UL, ORI’s
oversight review of UL’s investigation,
and additional evidence obtained and
analysis conducted by ORI during its
oversight review, ORI found that Dr.
Douglas D. Taylor, former Professor and
Vice Chair for Research, Department of
Obstetrics & Gynecology, UL, engaged in
research misconduct under 42 CFR part
93 in research supported by PHS funds,
specifically NCI, NIH, grants R41
CA139802 and R21 CA098166.
ORI found based on a preponderance
of the evidence that Respondent
intentionally, knowingly, or recklessly
used falsely labeled images to falsely
report data in figures, and in one
finding, intentionally, knowingly, or
recklessly plagiarized, reused, and
falsely labeled an image to falsely report
data in a figure. Respondent’s research
misconduct occurred in one (1) funded
PHS grant application, twelve (12)
unfunded PHS grant applications, and
two (2) PHS-supported published
papers. ORI found that these acts
constitute a significant departure from
accepted practices of the relevant
research community. The affected
papers and grant applications are:
• Patient-derived tumor-reactive
antibodies as diagnostic markers for
ovarian cancer. Gynecol. Oncol. 2009
Oct;115(1):112–20; doi: 10.1016/
j.ygyno.2009.06.031 (hereafter referred
to as ‘‘Gynecol. Oncol. 2009’’).
SUMMARY:
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• MicroRNA signatures of tumorderived exosomes as diagnostic
biomarkers of ovarian cancer. Gynecol.
Oncol. 2008 Jul;110(1):13–21; doi:
10.1016/j.ygyno.2008.04.033 (hereafter
referred to as ‘‘Gynecol. Oncol. 2008’’).
Corrigendum in: Gynecol. Oncol. 2010
Jan;116(1):153; doi: 10.1016/
j.ygyno.2009.10.045.
• R01 CA152218–01, ‘‘Exosomal
noncoding RNA for Lung Cancer Early
Detection,’’ submitted to NCI, NIH, on
10/05/2009, not funded.
• RC1 HD063778–01, ‘‘Circulating
exosomal microRNA in predicting
preterm birth,’’ submitted to the
National Institute of Child Health and
Human Development (NICHD), NIH, on
04/29/2009, not funded.
• R41 CA144598–01, ‘‘Use of
exosomal miRNA to diagnose pancreatic
cancer,’’ submitted to NCI, NIH, on 04/
10/2009, not funded.
• R01 CA132886–01A2,
‘‘Characterization of circulating lung
cancer-derived exosomal miRNA,’’
submitted to NCI, NIH, on 03/06/2009,
not funded.
• P50 CA142508–01, ‘‘University of
Louisville SPORE [Specialized Program
of Research Excellence] in Lung Cancer,
Project 2: Exosomal MicroRNAs as
Biomarkers for Lung Cancer,’’ submitted
to NCI, NIH, on 01/23/2009, not funded.
• R21 CA135269–01A1, ‘‘miRNA
methylation profiling of endometrial
cancer-associated exosomes,’’ submitted
to NCI, NIH, on 11/12/2008, not funded.
• R41 CA139802–01, ‘‘Exosomal
microRNA profiles as diagnostic
biomarkers of ovarian cancer,’’
submitted to NCI, NIH, on 05/28/2009,
funded, Project Award Dates: 09/23/
2009–08/31/2011.
• R01 CA132886–01A1,
‘‘Characterization of lung circulating
lung cancer-derived exosomal miRNA,’’
submitted to NCI, NIH, on 03/05/2008,
not funded.
• R41 CA135853–01, ‘‘Micro RNA
signatures of tumor-derived exosomes as
diagnostic biomarkers of cancer,’’
submitted to NCI, NIH, on 12/04/2007,
not funded.
• R21 CA135269–01, ‘‘Micro RNA
methylation in endometrial cancer,’’
submitted to NCI, NIH, on 10/16/2007,
not funded.
• R21 CA132886–01,
‘‘Characterization of circulating lung
cancer-derived exosomal miRNA,’’
submitted to NCI, NIH, on 06/04/2007,
not funded.
• R41 CA131011–01, ‘‘Circulating
exosomal microRNA as an Ovarian
Cancer Diagnostic,’’ submitted to NCI,
NIH, on 01/31/2007, not funded.
• R41 CA130498–01, ‘‘Serologically
Defined Diagnostic and Therapeutic
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Response Markers for Ovarian Cancer,’’
submitted to NCI, NIH, on 12/01/2006,
not funded.
Specifically, ORI found based on a
preponderance of the evidence that
Respondent engaged in research
misconduct by intentionally,
knowingly, or recklessly:
• falsifying and/or fabricating
research results by reusing parts of one
graph to show quantitation of
circulating tumor-derived exosomes
from patients with varying stages of:
—NSCLC (lung cancer) in Figure 5 of
R21 CA132886–01, R01 CA132886–
01A1, R01 CA132886–01A2, P50
CA142508–01, and R01 CA152218–01
—ovarian cancer in Figure 6 of R41
CA135853–01 and R41 CA139802–01
—pancreatic cancer in Figure 4 of R41
CA144598–01
• falsifying and/or fabricating
pancreatic cancer research results in
Figure 6 of R41 CA144598–01 by
omitting the word ‘‘ovarian’’ from the
label of the same image that was
previously labeled as ovarian cancer
tumor cells and circulating tumorderived exosomes in Figure 8 of R41
CA139802–01
• falsifying and/or fabricating
pancreatic cancer research results in
Figure 7 of R41 CA144598–01 by
relabeling and omitting the word
‘‘ovarian’’ from the label of the same
image that was previously labeled as
ovarian cancer tumors and exosomes
from these patients in Figure 3 of
Gynecol. Oncol. 2008 and Figure 9 of
R41 CA139802–01
• falsifying and/or fabricating
pancreatic cancer research results in
Figure 8 of R41 CA144598–01 by
relabeling and omitting the word
‘‘ovarian’’ from the label of the same
image that was previously labeled as
benign ovarian disease and ovarian
cancer in Figure 4 of Gynecol. Oncol.
2008 and Figure 10 of R41 CA139802–
01
• falsifying and/or fabricating
pancreatic cancer research results in
Figure 5 of R41 CA144598–01 by
relabeling and omitting the word
‘‘ovarian’’ from the label of the same
image that was previously used to show
data from ovarian cancer patients in
Figure 2 of Gynecol. Oncol. 2008, Figure
7 of R41 CA139802–01, and Figure 2 of
R21 CA135269–01A1
• falsifying and/or fabricating
research results by reusing a graph, first
claiming to show the isolation of the
miRNA fraction associated with
circulating tumor-derived exosomes
from an unnamed cancer in a grant
application focused on ovarian cancer
(Figure 6 of R41 CA131011–01) and to
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show the isolation of the miRNA
fraction associated with circulating
tumor exosomes in a subsequent grant
application on endometrial cancer
(Figure 6 of R21 CA135269–01); this
graph was then paired with a gel image
showing the RNA distribution from
tumor-derived exosomes from ovarian
cancer (Figure 6 of R01 CA132886–01);
the figure containing the graph paired
with the gel image was then used to also
represent exosomes derived from:
— unnamed cancer tumors in a grant
application on ovarian cancer (Figure
7 of R41 CA135853–01)
—lung cancer tumors (Figure 6 of R01
CA132886–01A1, R01 CA132886–
01A2, and P50 CA142508–01)
—placentas from preterm births (Figure
3 of RC1 HD063778–01)
• falsifying and/or fabricating
research results by reusing a single
image to show miRNAs expressed in
circulating exosomes from:
—ovarian cancer patients in five grant
applications (Figure 7 of R41
CA131011–01, Figure 7 of R21
CA135269–01, Figure 10 of R41
CA135853–01, Figure 4 of R21
CA135269–01A1, and Figure 11 of
R41 CA139802–01)
—lung cancer patients in four grant
applications (Figure 8 of R21
CA132886–01 and Figure 10 of R01
CA132886–01A1, R01 CA132886–
01A2, and P50 CA142508–01)
• falsifying and/or fabricating
research results by reusing a single
image from a non-PHS-supported paper
that claimed to demonstrate the
presence of antibodies that recognize
normal endometrium and endometrial
tumors, from the sera of women with
recurrent pregnancy loss (Figure 2A and
2B in a paper published in Fertil Steril.
2000 1), to represent the presence of
antibodies that recognize antigens from
normal epithelium and ovarian tumor
cell lines from patients with:
—stage II or IV ovarian cancer in Figure
4 of R41 CA130498–01
—stage I and stage IIIc ovarian cancer in
Figure 1 of Gynecol. Oncol. 2009
• plagiarizing, reusing, and relabeling
an electron micrograph of melanoma
derived exosomes created by a scientist
and published in Lancet 2 in 2002 to
falsely represent exosomes from patients
with:
—ovarian cancer in Figure 4B of R41
CA135853–01, Figure 1B of Gynecol.
1 Fertil Steril. 2000 Feb;73(2):305–13; doi:
10.1016/s0015–0282(99)00505–1 (hereafter referred
to as ‘‘Fertil Steril. 2000’’).
2 Lancet 2002 Jul 27;360(9329):295–305; doi:
10.1016/S0140–6736(02)09552–1 (hereafter referred
to as ‘‘Lancet 2002’’).
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Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices
Oncol. 2008, Figure 1B of R21
CA135269–01A1, Figure 4B of R41
CA139802–01, and Figure 2B of R41
CA144598–01
—NSCLC (lung cancer) in Figure 11B of
R01 CA132886–01A1, R01
CA132886–01A2, P50 CA142508–01,
and R01 CA152218–01
The following administrative actions
have been implemented:
(1) For a period of three (3) years,
beginning on October 17, 2022,
Respondent is debarred from
participating in ‘‘covered transactions’’
as defined in 42 CFR § 180.200 and
procurement transactions covered under
the Federal Acquisition Regulation (48
CFR chapter 1).
(2) Respondent is prohibited from
serving in any advisory capacity to PHS
including, but not limited to, service on
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant for a period of three (3) years,
beginning on October 17, 2022.
(3) In accordance with 42 CFR
93.407(a)(1) and 93.411(b), HHS will
send to the pertinent journal a notice of
ORI’s findings and the need for
retraction or correction of:
• Gynecol. Oncol. 2009 Oct;115(1):112–
20; doi: 10.1016/j.ygyno.2009.06.031
• Gynecol. Oncol. 2008 Jul;110(1):13–
21; doi: 10.1016/j.ygyno.2008.04.033
Dated: November 22, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity,
Office of the Assistant Secretary for Health.
[FR Doc. 2022–25866 Filed 11–25–22; 8:45 am]
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AGENCY: National Institutes of Health,
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ACTION: Notice.
In compliance with the
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and approval of the information
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of having their full effect if received
within 30-days of the date of this
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SUMMARY:
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73009
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]]>Agencies
[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73007-73009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25866]
-----------------------------------------------------------------------
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 Douglas
D. Taylor, Ph.D. (Respondent), former Professor and Vice Chair for
Research, Department of Obstetrics & Gynecology, University of
Louisville School of Medicine (UL). 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 R41 CA139802 and R21 CA098166. The
administrative actions, including debarment for a period of three (3)
years, were implemented beginning on October 17, 2022, and are detailed
below.
FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting
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:
Douglas D. Taylor, Ph.D., University of Louisville School of
Medicine: Based on the evidence and findings of investigations
conducted by UL, ORI's oversight review of UL's investigation, and
additional evidence obtained and analysis conducted by ORI during its
oversight review, ORI found that Dr. Douglas D. Taylor, former
Professor and Vice Chair for Research, Department of Obstetrics &
Gynecology, UL, engaged in research misconduct under 42 CFR part 93 in
research supported by PHS funds, specifically NCI, NIH, grants R41
CA139802 and R21 CA098166.
ORI found based on a preponderance of the evidence that Respondent
intentionally, knowingly, or recklessly used falsely labeled images to
falsely report data in figures, and in one finding, intentionally,
knowingly, or recklessly plagiarized, reused, and falsely labeled an
image to falsely report data in a figure. Respondent's research
misconduct occurred in one (1) funded PHS grant application, twelve
(12) unfunded PHS grant applications, and two (2) PHS-supported
published papers. ORI found that these acts constitute a significant
departure from accepted practices of the relevant research community.
The affected papers and grant applications are:
Patient-derived tumor-reactive antibodies as diagnostic
markers for ovarian cancer. Gynecol. Oncol. 2009 Oct;115(1):112-20;
doi: 10.1016/j.ygyno.2009.06.031 (hereafter referred to as ``Gynecol.
Oncol. 2009'').
[[Page 73008]]
MicroRNA signatures of tumor-derived exosomes as
diagnostic biomarkers of ovarian cancer. Gynecol. Oncol. 2008
Jul;110(1):13-21; doi: 10.1016/j.ygyno.2008.04.033 (hereafter referred
to as ``Gynecol. Oncol. 2008''). Corrigendum in: Gynecol. Oncol. 2010
Jan;116(1):153; doi: 10.1016/j.ygyno.2009.10.045.
R01 CA152218-01, ``Exosomal noncoding RNA for Lung Cancer
Early Detection,'' submitted to NCI, NIH, on 10/05/2009, not funded.
RC1 HD063778-01, ``Circulating exosomal microRNA in
predicting preterm birth,'' submitted to the National Institute of
Child Health and Human Development (NICHD), NIH, on 04/29/2009, not
funded.
R41 CA144598-01, ``Use of exosomal miRNA to diagnose
pancreatic cancer,'' submitted to NCI, NIH, on 04/10/2009, not funded.
R01 CA132886-01A2, ``Characterization of circulating lung
cancer-derived exosomal miRNA,'' submitted to NCI, NIH, on 03/06/2009,
not funded.
P50 CA142508-01, ``University of Louisville SPORE
[Specialized Program of Research Excellence] in Lung Cancer, Project 2:
Exosomal MicroRNAs as Biomarkers for Lung Cancer,'' submitted to NCI,
NIH, on 01/23/2009, not funded.
R21 CA135269-01A1, ``miRNA methylation profiling of
endometrial cancer-associated exosomes,'' submitted to NCI, NIH, on 11/
12/2008, not funded.
R41 CA139802-01, ``Exosomal microRNA profiles as
diagnostic biomarkers of ovarian cancer,'' submitted to NCI, NIH, on
05/28/2009, funded, Project Award Dates: 09/23/2009-08/31/2011.
R01 CA132886-01A1, ``Characterization of lung circulating
lung cancer-derived exosomal miRNA,'' submitted to NCI, NIH, on 03/05/
2008, not funded.
R41 CA135853-01, ``Micro RNA signatures of tumor-derived
exosomes as diagnostic biomarkers of cancer,'' submitted to NCI, NIH,
on 12/04/2007, not funded.
R21 CA135269-01, ``Micro RNA methylation in endometrial
cancer,'' submitted to NCI, NIH, on 10/16/2007, not funded.
R21 CA132886-01, ``Characterization of circulating lung
cancer-derived exosomal miRNA,'' submitted to NCI, NIH, on 06/04/2007,
not funded.
R41 CA131011-01, ``Circulating exosomal microRNA as an
Ovarian Cancer Diagnostic,'' submitted to NCI, NIH, on 01/31/2007, not
funded.
R41 CA130498-01, ``Serologically Defined Diagnostic and
Therapeutic Response Markers for Ovarian Cancer,'' submitted to NCI,
NIH, on 12/01/2006, not funded.
Specifically, ORI found based on a preponderance of the evidence
that Respondent engaged in research misconduct by intentionally,
knowingly, or recklessly:
falsifying and/or fabricating research results by reusing
parts of one graph to show quantitation of circulating tumor-derived
exosomes from patients with varying stages of:
--NSCLC (lung cancer) in Figure 5 of R21 CA132886-01, R01 CA132886-
01A1, R01 CA132886-01A2, P50 CA142508-01, and R01 CA152218-01
--ovarian cancer in Figure 6 of R41 CA135853-01 and R41 CA139802-01
--pancreatic cancer in Figure 4 of R41 CA144598-01
falsifying and/or fabricating pancreatic cancer research
results in Figure 6 of R41 CA144598-01 by omitting the word ``ovarian''
from the label of the same image that was previously labeled as ovarian
cancer tumor cells and circulating tumor-derived exosomes in Figure 8
of R41 CA139802-01
falsifying and/or fabricating pancreatic cancer research
results in Figure 7 of R41 CA144598-01 by relabeling and omitting the
word ``ovarian'' from the label of the same image that was previously
labeled as ovarian cancer tumors and exosomes from these patients in
Figure 3 of Gynecol. Oncol. 2008 and Figure 9 of R41 CA139802-01
falsifying and/or fabricating pancreatic cancer research
results in Figure 8 of R41 CA144598-01 by relabeling and omitting the
word ``ovarian'' from the label of the same image that was previously
labeled as benign ovarian disease and ovarian cancer in Figure 4 of
Gynecol. Oncol. 2008 and Figure 10 of R41 CA139802-01
falsifying and/or fabricating pancreatic cancer research
results in Figure 5 of R41 CA144598-01 by relabeling and omitting the
word ``ovarian'' from the label of the same image that was previously
used to show data from ovarian cancer patients in Figure 2 of Gynecol.
Oncol. 2008, Figure 7 of R41 CA139802-01, and Figure 2 of R21 CA135269-
01A1
falsifying and/or fabricating research results by reusing
a graph, first claiming to show the isolation of the miRNA fraction
associated with circulating tumor-derived exosomes from an unnamed
cancer in a grant application focused on ovarian cancer (Figure 6 of
R41 CA131011-01) and to show the isolation of the miRNA fraction
associated with circulating tumor exosomes in a subsequent grant
application on endometrial cancer (Figure 6 of R21 CA135269-01); this
graph was then paired with a gel image showing the RNA distribution
from tumor-derived exosomes from ovarian cancer (Figure 6 of R01
CA132886-01); the figure containing the graph paired with the gel image
was then used to also represent exosomes derived from:
-- unnamed cancer tumors in a grant application on ovarian cancer
(Figure 7 of R41 CA135853-01)
--lung cancer tumors (Figure 6 of R01 CA132886-01A1, R01 CA132886-01A2,
and P50 CA142508-01)
--placentas from preterm births (Figure 3 of RC1 HD063778-01)
falsifying and/or fabricating research results by reusing
a single image to show miRNAs expressed in circulating exosomes from:
--ovarian cancer patients in five grant applications (Figure 7 of R41
CA131011-01, Figure 7 of R21 CA135269-01, Figure 10 of R41 CA135853-01,
Figure 4 of R21 CA135269-01A1, and Figure 11 of R41 CA139802-01)
--lung cancer patients in four grant applications (Figure 8 of R21
CA132886-01 and Figure 10 of R01 CA132886-01A1, R01 CA132886-01A2, and
P50 CA142508-01)
falsifying and/or fabricating research results by reusing
a single image from a non-PHS-supported paper that claimed to
demonstrate the presence of antibodies that recognize normal
endometrium and endometrial tumors, from the sera of women with
recurrent pregnancy loss (Figure 2A and 2B in a paper published in
Fertil Steril. 2000 \1\), to represent the presence of antibodies that
recognize antigens from normal epithelium and ovarian tumor cell lines
from patients with:
---------------------------------------------------------------------------
\1\ Fertil Steril. 2000 Feb;73(2):305-13; doi: 10.1016/s0015-
0282(99)00505-1 (hereafter referred to as ``Fertil Steril. 2000'').
--stage II or IV ovarian cancer in Figure 4 of R41 CA130498-01
--stage I and stage IIIc ovarian cancer in Figure 1 of Gynecol. Oncol.
2009
plagiarizing, reusing, and relabeling an electron
micrograph of melanoma derived exosomes created by a scientist and
published in Lancet \2\ in 2002 to falsely represent exosomes from
patients with:
---------------------------------------------------------------------------
\2\ Lancet 2002 Jul 27;360(9329):295-305; doi: 10.1016/S0140-
6736(02)09552-1 (hereafter referred to as ``Lancet 2002'').
--ovarian cancer in Figure 4B of R41 CA135853-01, Figure 1B of Gynecol.
[[Page 73009]]
Oncol. 2008, Figure 1B of R21 CA135269-01A1, Figure 4B of R41 CA139802-
01, and Figure 2B of R41 CA144598-01
--NSCLC (lung cancer) in Figure 11B of R01 CA132886-01A1, R01 CA132886-
01A2, P50 CA142508-01, and R01 CA152218-01
The following administrative actions have been implemented:
(1) For a period of three (3) years, beginning on October 17, 2022,
Respondent is debarred from participating in ``covered transactions''
as defined in 42 CFR Sec. 180.200 and procurement transactions covered
under the Federal Acquisition Regulation (48 CFR chapter 1).
(2) Respondent is prohibited from serving in any advisory capacity
to PHS including, but not limited to, service on any PHS advisory
committee, board, and/or peer review committee, or as a consultant for
a period of three (3) years, beginning on October 17, 2022.
(3) In accordance with 42 CFR 93.407(a)(1) and 93.411(b), HHS will
send to the pertinent journal a notice of ORI's findings and the need
for retraction or correction of:
Gynecol. Oncol. 2009 Oct;115(1):112-20; doi: 10.1016/
j.ygyno.2009.06.031
Gynecol. Oncol. 2008 Jul;110(1):13-21; doi: 10.1016/
j.ygyno.2008.04.033
Dated: November 22, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2022-25866 Filed 11-25-22; 8:45 am]
BILLING CODE 4150-31-P
