[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]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Misconduct in Science
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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:
1 P01 HD40540-01 (National Institute of Child Health and
Human Development [NICHD], National Institutes of Health [NIH])
5 P01 HD40540-02 (NICHD, NIH)
1 P01 AI057005-01 (National Institute of Allergy and
Infectious Diseases [NIAID], NIH)
1 R01 DE014149-01 (National Institute of Dental and
Craniofacial Research [NIDCR], NIH)
2 U01 AI41535-05 (NIAID, NIH)
1 R01 HL072631-01 (National Heart, Lung, and Blood
Institute [NHLBI], NIH)
1 R01 (U01) AI054334-01 (NIAID, NIH)
1 R01 DE014827-01 (NIDCR, NIH)
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