[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Notices]
[Pages 23255-23256]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Misconduct in Science/Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Notice is hereby given that effective on March 14, 2013, a 
Settlement Agreement was made and entered into by and between Dr. 
Philippe Bois and the United States Department of Health and Human 
Services (HHS), Kathleen Sebelius, Howard K. Koh, Nancy Gunderson, and 
Donald Wright (collectively HHS) by and through the United States 
Attorney for the District of Columbia in Bois v. HHS, et al., Civil 
Action no. 11-cv-1563, which was pending before the U.S. District Court 
for the District of Columbia.
    In the Settlement Agreement, HHS and Dr. Bois agreed to settle the 
proceedings before the District Court of the District of Columbia as 
well as to resolve all administrative matters pending at HHS.
    ORI found that Philippe Bois, Ph.D., former postdoctoral fellow, 
Department of Biochemistry, St. Jude Children's Research Hospital, 
engaged in research misconduct in research funded by National Institute 
of General Medical Sciences (NIGMS), National Institutes of Health 
(NIH), grant R01 GM071596, and National Cancer Institute (NCI), NIH, 
grants P30 CA021765, P01 CA071907, R01 CA072996, and R01 CA100603.
    In the Settlement Agreement, the parties agreed that ORI found by a 
preponderance of the evidence that the Respondent committed misconduct 
in science and research misconduct by:
    1. Knowingly and intentionally falsely reporting that FOXO1a was 
not expressed in cell lysates from alveolar rhabdomyosarcoma (ARMS) 
tumor biopsies, by selecting a specific FOX01a immunoblot to show the 
desired result, in Figure 1A of the following paper: Bois, P.R., 
Izeradjene, K., Houghton, P.J., Cleveland, J.L., Houghton, J.A., & 
Grosveld, C.G. ``FOXO1a acts as a selective tumor suppressor in 
alveolar rhabdomyosarcoma.'' J. Cell. Biol. 170:903-912, September 2005 
(``JCB 2005'')
    2. Falsifying data showing SDS-PAGE for papain digestion of VBS3 
and [alpha]VBS, by falsely labeling lane 1 to represent papain only 
digestion, by falsely labeling lane 5 to represent papain digestion of 
the [alpha]VBS peptide, and by falsely inserting a band in lane 3 to 
represent the [alpha]VBS peptide, in Figure 4B of the following paper: 
Bois, P.R., Borgon, R.A., Vornhein, C., & Izard, T. ``Structural 
dynamics of [alpha]-actinin-vinculin interactions.'' Mol. Cell. Biol. 
25:6112-6122, July 2005 (``MCB 2005'').
    The parties further agreed that Dr. Bois denied committing research 
misconduct and, pursuant to 42 CFR part 93, filed a timely request for 
a hearing at which to contest ORI's findings. An HHS Administrative Law 
Judge (ALJ) denied Dr. Bois' request for a hearing. HHS subsequently 
entered a debarment order against Dr. Bois. Dr. Bois filed the above 
referenced lawsuit in the United States District Court for the District 
of Columbia asking the Court to vacate the debarment order and remand 
the matter for further proceedings before HHS, including but not 
limited to granting Dr. Bois' request for a hearing.
    On March 2, 2012, Judge Berman Jackson of the United States 
District Court for the District of Columbia issued an order vacating 
HHS' debarment order, affirming Finding 1, and remanding the 
matter to HHS for further proceedings regarding Finding 2. On 
March 30, 2012, HHS filed a Motion for Reconsideration before Judge 
Berman Jackson.
    On March 14, 2013, Dr. Bois and HHS entered into a Settlement 
Agreement (Agreement) to settle and dismiss the pending civil action. 
The terms of the

[[Page 23256]]

Settlement Agreement include that Dr. Bois denied that he committed 
research misconduct but he agreed not to further appeal ORI's findings 
of research misconduct set-forth above. Dr. Bois and HHS further agreed 
to the following administrative actions beginning on March 14, 2013:
    (1) To have his research supervised for a period of three (3) years 
beginning on the effective date of the Agreement; he agreed that prior 
to the submission of an application for U.S. Public Health Service 
(PHS) support for a research project on which his participation is 
proposed and prior to his participation in any capacity on PHS-
supported research, he shall ensure that a plan for supervision of his 
duties is submitted to ORI for approval; the supervision plan must be 
designed to ensure the scientific integrity of his research 
contribution; he agreed that he shall not participate in any PHS-
supported research until such a supervision plan is submitted to and 
approved by ORI, with such review and approval to be conducted promptly 
by ORI and not unreasonably withheld; he agreed to maintain 
responsibility for compliance with the agreed upon supervision plan;
    (2) that for three (3) years beginning with the effective date of 
the Agreement, 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 Dr. Bois is 
involved, a certification to ORI that the data provided by him 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; and
    (3) to exclude himself voluntarily 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 years (3) beginning with the effective 
date of the Agreement.
    Dr. Bois further agreed to dismiss his lawsuit with prejudice and 
to withdraw further proceedings before HHS. Dr. Bois and HHS both 
agreed to waive or abandon all other claims. This notice supercedes the 
notice regarding this matter that was previously published in: Federal 
Register 76:111, June 9, 2011.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852, (240) 453-8800.

David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013-09134 Filed 4-17-13; 8:45 am]
BILLING CODE 4150-31-P