[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Nature,\1\ which was subsequently voluntarily withdrawn.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]
 BILLING CODE 4150-31-P