Notice Number: NOT-OD-15-131

Key Dates
Release Date: July 28, 2015

Issued by
Department of Health and Human Services (DHHS)

Purpose

SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Julia Bitzegeio, Ph.D., Aaron Diamond AIDS Research Center: Based on the Respondent's admission, an assessment conducted by the Aaron Diamond AIDS Research Center (ADARC), and analysis conducted by ORI in its oversight review, ORI found that Dr. Julia Bitzegeio, former Postdoctoral Fellow, ADARC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI078788, R21
AI093255, and R37 AI064003.

ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in one (1) publication, two (2) unfunded grant applications, and one (1) unpublished manuscript:

• Journal of Virology 87:3549-3560, 2013 (hereafter referred to as “JVI 2013”)
• R01 AI114367-01A1
• R01 AI120787-01
• “A single amino acid in the CD4 binding site of HIV-1 Env is a key determinant of species tropism.” Unpublished manuscript

Specifically, ORI found that:

1. Respondent falsified and/or fabricated in vitro rates of viral replication or infection in human and macaque lymphocytes and infectious titers on reporter cells, for multiple strains of SIV based chimeric viruses such that the results were not accurately represented in:

• Figure 7 in JVI 2013
• Figures 6B and 8C in R01 AI114367-01A1
• Figures 1, 2B, and 3B in R01 AI120787-01
• Figures 1A-D, 2D, 3D, 5A-C, 5I, 6C, and S3D in the unpublished manuscript

2. Respondent falsified and/or fabricated in vitro binding data of SIV based chimeric viruses to human or macaque CD4 such that the results were not accurately represented in:

• Figure 6 in R01 AI120787-01
• Figures 5D-F in the unpublished manuscript

ADARC has submitted a request for correction of JVI 2013.

Dr. Bitzegeio has entered into a Voluntary Settlement Agreement and
has voluntarily agreed:

(1) That if within three (3) years from the effective date of the Agreement, Respondent receives or applies for U.S Public Health Service (PHS) support, Respondent agreed to have her research supervised for a period of three (3) years beginning on the date of her employment in a position in which she receives or applies for PHS support and to notify her employer(s)/institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is
proposed and prior to her participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan;

(2) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed that any institution employing her shall submit in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent 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 herself 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 (3) years, beginning on June 23, 2015.

Inquiries

Please direct all inquiries to:

Donald Wright, M.D., M.P.H.
Acting Director
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
Telephone: 240-453-8800