[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Notices]
[Pages 24703-24704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Misconduct in Science

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Notice is hereby given that on March 18, 2010, the Department 
of Health and Human Services (HHS) Debarring Official, on behalf of the 
Secretary of HHS, issued a final notice of debarment based on the 
misconduct in science findings of the Office of Research Integrity 
(ORI) in the following case:
    Scott J. Brodie, DVM, Ph.D., University of Washington: Based on the 
findings in an investigation report by the University of Washington 
(UW) and additional analysis conducted by ORI in its oversight review, 
ORI found that Scott J. Brodie, DVM, Ph.D., former Research Assistant 
Professor, Department of Laboratory Medicine, and Director of the UW 
Retrovirology Pathogenesis Laboratory, UW, committed misconduct in 
science (scientific misconduct) in research supported by or reported in 
the following U.S. Public Health Service (PHS) grant applications:
    <bullet> 1 P01 HD40540-01 (National Institute of Child Health and 
Human Development [NICHD], National Institutes of Health [NIH])
    <bullet> 5 P01 HD40540-02 (NICHD, NIH)
    <bullet> 1 P01 AI057005-01 (National Institute of Allergy and 
Infectious Diseases [NIAID], NIH)
    <bullet> 1 R01 DE014149-01 (National Institute of Dental and 
Craniofacial Research [NIDCR], NIH)
    <bullet> 2 U01 AI41535-05 (NIAID, NIH)
    <bullet> 1 R01 HL072631-01 (National Heart, Lung, and Blood 
Institute [NHLBI], NIH)
    <bullet> 1 R01 (U01) AI054334-01 (NIAID, NIH)
    <bullet> 1 R01 DE014827-01 (NIDCR, NIH)
    <bullet> 1 R01 AI051954-01 (NIAID, NIH).
    Specifically, ORI made fifteen findings of misconduct in science 
based on evidence that Dr. Brodie knowingly and intentionally 
fabricated and falsified data reported in nine PHS grant applications 
and progress reports and several published papers, manuscripts, and 
PowerPoint presentations. The fifteen findings are as follows:
    1. Respondent knowingly and intentionally falsified a figure that 
was presented in manuscripts submitted to the Journal of Experimental 
Medicine and the Journal of Virology and in several PowerPoint 
presentations that purported to represent rectal mucosal leukocytes in 
some instances and lymph nodes in other instances.
    2. Respondent knowingly and intentionally falsified portions of a 
three-paneled figure included in several manuscript submissions, 
PowerPoint presentations, and grant applications.
    3. Respondent knowingly and intentionally falsified a figure 
included as Figure 1N in American Journal of Pathology 54:1453-1464, 
1999, three NIH grant applications, and several PowerPoint 
presentations.
    4. Respondent knowingly and intentionally falsified a figure that 
was published as an insert within Figure 1K in American Journal of 
Pathology 54:1453, 1999 and included the figure in a number of NIH 
grant applications.
    5. Respondent knowingly and intentionally falsified a figure 
representing a panel of four green fluorescent cells and included it as 
a figure in several grant applications claiming that each cell had been 
subjected to different treatments when three of the cells came from a 
single image.
    6. Respondent knowingly and intentionally falsified an image 
included as Figure 5A in a paper published in the Journal of Clinical 
Investigations 105:1407, 2000 and submitted to various journals and 
included in different grant applications.
    7. Respondent knowingly and intentionally falsified a figure 
appearing as Figure 3.III.A, inset, in a manuscript submitted to 
Science entitled ``A persistent reservoir of HIV-1 in pulmonary 
macrophages'' and as figures in various grant applications and 
PowerPoint presentations.
    8. Respondent knowingly and intentionally falsified multiple 
versions of a figure depicting green and red fluorescent cells used as 
Figures 3.III.H and I in a manuscript submitted to Science, as Figures 
6C and 6D of NIDCR, NIH, grant application 1 R01 DE14827-01, as Figures 
C.2.1 1H and C.2.11I of NHLBI, NIH, grant application 1 R01 HL072631-
01, and in PowerPoint presentations.
    9. Respondent knowingly and intentionally falsified a figure, 
labeled as Figure 9E in NIDCR, NIH, grant application 1 R01 DE014827-01 
and in various other grant applications and PowerPoint presentations.
    10. Respondent knowingly and intentionally falsified the bottom 
half of Figure C.2.5 of NHLBI, NIH, grant application 1 R01 HL072631-01 
by using the same image twice, labeling it once as being treated for 2 
hours with lipopolysaccharide (LPS) and the second as being treated for 
12 hours

[[Page 24704]]

with LPS. Respondent also used a second image twice, labeling it once 
as ``no LPS'' and the second time as ``24 hours with LPS.''
    11. Respondent knowingly and intentionally falsified a figure that 
purports to represent viral decay in rectal mucosa and included the 
figure as a slide in two PowerPoint presentations and three NIH grant 
applications.
    12. Respondent knowingly and intentionally falsified: (a) A 
histopathology figure that was described in a paper published in the 
Journal of Infectious Diseases 83:1466, 2001, as inguinal lymph nodes 
from an untreated AIDS patient using in situ PCR to show the presence 
of HIV-1 cells when it was actually from a tissue expressing the 
neomycin marker; (b) the gel images resembling Figures 2A and C, which 
Respondent claimed to be based on lymph node cells, although he 
reported the gel images elsewhere to represent results from rectal 
tissue; and (c) various versions of these blots that Respondent 
reported elsewhere and labeled differently with respect to the copy 
numbers detected and as detecting DNA in some instance and RNA in 
others.
    13. Respondent knowingly and intentionally falsified Figures 2DI 
and 2DII included in a paper published in the Journal of Leukocyte 
Biology 68:351-359, 2000.
    14. Respondent knowingly and intentionally falsified Figure 4, 
Panels A and B, in NIDCR, NIH, grant application 1 R01 DE014827-01 by 
manipulating the source images.
    15. Respondent knowingly and intentionally falsified a number of 
figures and made false statements in the text of NIAID, NIH, grant 
application 1 R01 AI051954-01 submitted jointly with a colleague by 
relabeling figures based on research carried out with HIV-1 or HIV-2 
and identifying the figures and text as research conducted with ovine 
lentivirus (OvLV).
    ORI issued a charge letter enumerating the above findings of 
misconduct in science and proposing HHS administrative actions. Dr. 
Brodie subsequently requested a hearing before an Administrative Law 
Judge (ALJ) of the Departmental Appeals Board to dispute these 
findings. In January 2009, the ALJ issued a ruling holding that there 
were no triable issues challenging ORI's findings that there were 
materially false statements, images, and other data in the relevant 
publications, presentations, and grant applications. However, the ALJ 
held that Dr. Brodie raised triable issues about his intent to commit 
scientific misconduct and the reasonableness of the proposed debarment 
of seven (7) years.
    On January 12, 2010, the ALJ issued a recommended decision to the 
HHS Assistant Secretary for Health (ASH) granting summary disposition 
to ORI. The ALJ also stated that Dr. Brodie committed scientific 
misconduct on multiple occasions and that its extent amply justified 
debarment for a period of seven (7) years. Pursuant to 42 CFR 
93.523(c), the ASH forwarded the ALJ's recommended decision to the HHS 
Debarring Official, which constituted the findings of fact required 
under 2 CFR parts 180 and 376.
    On February 1, 2010, Dr. Brodie submitted a letter to the HHS 
Debarring Official with attachments to request that the ALJ's 
recommended decision be rejected as a whole. On February 26, 2010, Dr. 
Brodie submitted a letter requesting the opportunity to meet with the 
HHS Debarring Official to orally present the reasons supporting his 
request that the ALJ's recommended decision be rejected. However, the 
HHS Debarring Official determined that Dr. Brodie had been afforded an 
opportunity to contest ORI's findings of scientific misconduct in 
accordance with 42 CFR part 93, subpart E. Given the findings of facts 
in this case, the HHS Debarring Official determined that the issues in 
his presentation in opposition to the ALJ's recommended decision did 
not raise a genuine dispute over facts material to the recommended 
debarment. Accordingly, the HHS Debarring Official also denied Dr. 
Brodie's request to make an oral presentation and issued a notice of 
debarment to begin on March 18, 2010, and end on March 17, 2017.
    On March 23, 2010, Dr. Brodie submitted a letter requesting a 
postponement of the effective date of the debarment. This request was 
denied by the Debarring Official on April 6, 2010.
    Thus, the misconduct in science findings set forth above became 
effective, and the following administrative actions have been 
implemented for a period of seven (7) years, beginning on March 18, 
2010:
    (1) Dr. Brodie has been debarred from any contracting or 
subcontracting with any agency of the United States Government and from 
eligibility or involvement in nonprocurement programs of the United 
States Government referred to as ``covered transactions'' pursuant to 
the Department of Health and Human Service's Implementation (2 CFR part 
376 et seq.) of OMB Guidelines to Agencies on Governmentwide Debarment 
and Suspension, 2 CFR part 180; and
    (2) Dr. Brodie 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 consultant.

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

John Dahlberg,
Director, Division of Investigative Oversight, Office of Research 
Integrity.
[FR Doc. 2010-10605 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-17-P