[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12264-12265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06206]
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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
[[Page 12265]]
Edward J. Fox, Ph.D. (Respondent), Acting Assistant Professor in the
Department of Pathology, University of Washington (UW). Dr. Fox engaged
in research misconduct in research supported by National Cancer
Institute (NCI), National Institutes of Health (NIH), grants R01
CA193649, R01 CA160674, P01 CA77852, and R01 CA102029. The
administrative actions, including supervision for a period of one (1)
year, were implemented beginning on March 18, 2019, and are detailed
below.
FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr. P.H., Interim
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, 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:
Edward J. Fox, Ph.D., University of Washington: Based on
Respondent's admission, an inquiry conducted by UW, and additional
analysis conducted by ORI in its oversight review, ORI found that Dr.
Edward J. Fox, Acting Assistant Professor in the Department of
Pathology, UW, engaged in research misconduct in research supported by
NCI, NIH, grants R01 CA193649, R01 CA160674, P01 CA77852, and R01
CA102029.
Respondent neither admits nor denies ORI's finding of research
misconduct related to grant application R01 CA193649-01A1. Respondent
and ORI desire to close this matter without further expense of time and
other resources and thus have entered into a Voluntary Settlement
Agreement (Agreement). With respect to grant application R01 CA193649-
01A1, Respondent acknowledges that his research records were poorly
maintained and lacked the documentation necessary to support the
reported preliminary results.
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, or recklessly:
Fabricating data and analyses in a manuscript submitted to
Nature,\1\ which was subsequently voluntarily withdrawn. These
fabricated data and analyses also appear in Figure 1 of grant progress
report R01 CA193649-02.\2\ Respondent stated during the inquiry that
two abstracts that appear in Cancer Research \3\ are based on the
fabricated data and analyses.
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\1\ Fox, E.J., Schmitt, M.W., Reid-Bayliss, K.S., Geraghty, R.,
O'Donoghue, D.P., Mulcahy, H.E., Leahy, D.T., Sheahan, K., Beckman,
R.A., & Loeb, L.A. ``Extensive subclonal mutations in human
colorectal cancers detected by duplex sequencing.'' Accepted for
publication in Nature (hereafter referred to as the ``Nature
manuscript'').
\2\ The subsequent grant progress report noted these data might
not be reliable and indicated that the experiments were being re-
run.
\3\ Fox, E.J.P., Schmitt, M.W., Reid-Bayliss, K.S., Beckman,
R.A., & Loeb, L.A. ``Extensive subclonal mutations in human
colorectal cancers detected by duplex sequencing.'' [Abstract]. In:
Proceedings of the 107th Annual Meeting of the American Association
for Cancer Research, 2016 Apr 16-20, New Orleans, LA. Philadelphia
(PA): AACR; Cancer Res. 76(14 Suppl):Abstract nr LB-338, 2016.
Fox, E.J.P., Schmitt, M.W., Reid-Bayliss, K.S., Beckman, R.A., &
Loeb, L.A. ``Extensive subclonal mutations in human colorectal
cancers detected by Duplex Sequencing.'' [Abstract]. In: Proceedings
of the AACR Special Conference on Colorectal Cancer: From Initiation
to Outcomes, 2016 Sep 17-20, Tampa, FL. Philadelphia (PA): AACR;
Cancer Res. 77(3 Suppl):Abstract nr A08, 2017.
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fabricating or falsifying data and analyses in the
preliminary results section of grant application R01 CA193649-01A1,
section C.1.a(iv).
Specifically, ORI found that in the Nature manuscript and, where
noted below, in grant progress report R01 CA193649-02 submitted to NCI,
NIH, Respondent intentionally, knowingly, or recklessly:
Fabricated data for Figures 1c and 1d to show that the
frequency of unique subclonal mutations in normal cells increases as
people age, while the frequency of subclonal mutations in cancerous
cells does not.
fabricated Figure 2b to show a pattern of subclonal
mutations for the fabricated data from Figures 1c and 1d and fabricated
the statistical analysis results to show statistically significant
differences between tumor and normal mucosa; this figure also appears
as Figure 1 in R01 CA193649-02.
fabricated data for Figure 3b to show predominantly
neutral subclonal evolution.
fabricated the Extended Data Figures 1-5 and Extended Data
Tables 3-5 by using the fabricated data from Figure 3b.
presented methods and data-based explanations that are
fabricated because they were based on the fabricated data.
ORI also specifically found that in grant application R01 CA193649-
01A1, Respondent intentionally, knowingly, or recklessly:
Fabricated or falsified data for Figures 7, 8, and 9 to
show how duplex sequencing methodology can document the distribution of
subclonal mutations that are present in colorectal cancer.C
presented data-based explanations that are fabricated or
falsified because some of them were based on the fabricated or
falsified data.
Dr. Fox entered into an Agreement and voluntarily agreed:
(1) To have his research supervised for a period of one (1) year
beginning on March 18, 2019; Respondent agreed that prior to submission
of an application for U.S. Public Health Service (PHS) support for a
research project on which 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 contribution; Respondent agreed that he shall not
participate in any PHS-supported research until such a supervision plan
is submitted to and approved by ORI; Respondent agreed to maintain
responsibility for compliance with the agreed upon supervision plan;
(2) that for a period of one (1) year beginning on March 18, 2019,
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;
(3) that if no supervisory plan is provided to ORI, Respondent will
provide certification to ORI at the conclusion of the supervision
period that he has not engaged in, applied for, or had his name
included on any application, proposal, or other request for PHS funds
without prior notification to ORI;
(4) to exclude himself 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
one (1) year beginning on March 18, 2019; and
(5) as a condition of the Agreement, Respondent will recommend to
the American Association for Cancer Research that the following two
Cancer Research abstracts should be retracted:
Cancer Res. 76(14 Suppl.):Abstract nr LB-338, 2016
Cancer Res. 77(3 Suppl.):Abstract nr A08, 2017
Respondent will copy ORI and UW on this correspondence.
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2019-06206 Filed 3-29-19; 8:45 am]
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