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###### Department of Health and Human Services

###### Office of the Secretary

# 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                               ( print 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