[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Notices]
[Pages 77467-77468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30424]


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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: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Dong-Pyou Han, Ph.D., Iowa State University of Science and 
Technology: Based on the report of an inquiry conducted by the Iowa 
State University of Science and Technology (ISU), a detailed admission 
by the Respondent, and additional analysis conducted by ORI, ORI and 
ISU found that Dr. Dong-Pyou Han, former Research Assistant Professor, 
Department of Biomedical Services, ISU, engaged in research misconduct 
in research supported by National Institute of Allergy and Infectious 
Diseases (NIAID), National Institutes of Health (NIH), grants P01 
AI074286, R33 AI076083, and U19 AI091031.
    ORI and ISU found that the Respondent falsified results in research 
to develop a vaccine against human immunodeficiency virus-1 (HIV-1) by 
intentionally spiking samples of rabbit sera with antibodies to provide 
the desired results. The falsification made it appear that rabbits 
immunized with the gp41-54 moiety of the HIV gp41 glycoprotein induced 
antibodies capable of neutralizing a broad range of HIV-1 strains, when 
the original sera were weakly or non-reactive in neutralization assays. 
Falsified neutralization assay results were widely reported in 
laboratory meetings, seven (7) national and international symposia 
between 2010 and 2012, and in grant applications and progress reports 
P01 AI074286-03, -04, -05, and -06; R33 AI076083-04; U19 AI091031-01 
and -03; and R01 AI090921-01. Specifically:
    a. Respondent falsified research materials when he provided 
collaborators with sera for neutralization assays from (i) rabbits 
immunized with peptides from HIV gp41-54Q (and related antigens HR1-
54Q, gp41-54Q-OG, gp41-54Q-GHC, gp41-54Q-Cys and Cys-gp41-54Q) to assay 
HIV neutralizing activity, when Respondent had spiked the samples with 
human IgG known to contain broadly neutralizing antibodies to HIV-1; 
and (ii) rabbits immunized with HIV gp41-54Q to assay HIV neutralizing 
activity, when Respondent had spiked the samples with sera from rabbits 
immunized with HIV-1 gp120 that neutralized HIV.
    b. Respondent falsified data files for neutralization assays, and 
provided

[[Page 77468]]

false data to his laboratory colleagues, to make it appear that rabbits 
immunized with gp41-54Q and recombinant Lactobacillus expressing gp41-
64 (LAB gp41-64) produced broadly reactive neutralizing antibodies, by 
changing the numbers to show that samples with little or no 
neutralizing activity had high activity.
    Dr. Han has entered into a Voluntary Exclusion Agreement and has 
voluntarily agreed for a period of three (3) years, beginning on 
November 25, 2013:
    (1) To exclude himself 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 HHS' Implementation 
(2 CFR Part 376 et seq) of OMB Guidelines to Agencies on Governmentwide 
Debarment and Suspension, 2 CFR Part 180 (collectively the ``Debarment 
Regulations''); and
    (2) to exclude himself voluntarily from serving in any advisory 
capacity to the U.S. Public Health Service (PHS) including, but not 
limited to, service on any PHS advisory committee, board, and/or peer 
review committee, or as a consultant.

FOR FURTHER INFORMATION CONTACT: Director, 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. 2013-30424 Filed 12-20-13; 8:45 am]
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