[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]


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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 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:
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    \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:
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    \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