SUPPLEMENTARY INFORMATION:

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

Janina Jiang, M.D., Ph.D., University of California, Los Angeles: Based on the report of an investigation conducted by UCLA and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Janina Jiang, former Assistant Researcher in the Department of Pathology & Laboratory Medicine at the David Geffen School of Medicine, UCLA, engaged in research misconduct in research included in grant applications submitted for PHS funds, specifically R43 CA228629-01 submitted to NCI, NIH, UL1 TR000124 submitted to NCATS, NIH, and P01 AI131294-01, R01 AI126914-01, R21 AI131013-01, R21 AI131451-01, R21 AI131451-01A1, R21 AI142068-01, R43 AI136224-01, R44 AI126960-01, and R44 AI128983-01 submitted to NIAID, NIH.

ORI found that Respondent engaged in research misconduct by knowingly and recklessly falsifying and/or fabricating flow cytometry data that were included in the following eleven (11) grant applications submitted for PHS funds:

• R43 CA228629-01, “CTL Based Therapeutic Vaccine to Prevent or Interrupt HPV Mediated Oncogenesis,” submitted to NCI, NIH, Awarded Project Dates: September 18, 2018-February 29, 2020.
• UL1 TR000124, “UCLA Clinical and Translational Science Institute,” submitted to NCATS, NIH, Awarded Project Dates: June 1, 2011-August 31, 2016.
• P01 AI131294-01, “Defining Factors Controlling HIV Rebound,” submitted to NIAID, NIH, Awarded Project Dates: August 10, 2017-July 31, 2022.
• R01 AI126914-01, “A Recombinant Human Vault CTL-Based HIV Vaccine Component,” submitted to NIAID, NIH, on December 23, 2015.
• R21 AI131013-01, “A Novel Cellular Immune Zika Vaccine,” submitted to NIAID, NIH, on June 14, 2016.
• R21 AI131451-01, “A Novel Therapeutic Vaccine for HPV Oncogenesis,” submitted to NIAID, NIH, on June 14, 2016.
• R21 AI131451-01A1, “A Novel Therapeutic Vaccine for HPV Oncogenesis,” submitted to NIAID, NIH, on June 13, 2017.
• R21 AI142068-01, “A Novel Therapeutic Vaccine for HPV Oncogenesis,” submitted to NIAID, NIH, on February 12, 2018.
• R43 AI136224-01, “Development of A Novel Pan-Serovar Vaccine for Chlamydia,” submitted to NIAID, NIH, on April 5, 2017.
• R44 AI126960-01, “Novel Pan-Serovar Vaccine for Chlamydia,” submitted to NIAID, NIH, on January 4, 2016.
• R44 AI128983-01, “Design of a Novel CTL Retargeting Therapeutic HIV Vaccine,” submitted to NIAID, NIH, on April 2, 2016.

ORI found that Respondent knowingly and recklessly falsified and/or fabricated flow cytometry data to represent interferon-γ (IFN-γ) expression in immune cells of mice administered with human recombinant vaults such that the represented data were incompatible with the raw experimental data. Specifically, Respondent falsified and/or fabricated flow cytometry data to represent:

• IFN-γ expression in the immune cells of mice injected subcutaneously or intranasally with human recombinant vaults containing HIV Gag peptides such that the vaccinated arm of the experiment showed antigen-specific T-cell responses in:

—Figure 6 of UL1 TR000124

—Figure 2 of R43 CA228629-01

—Figure 8 of R21 AI131451-01

—Figure 9 of R21 AI131451-01A1

—Figure 9 of R44 AI126960-01

—Figure 3 of R43 AI136224-01

—Figure 9 of R21 AI131013-01

—Figure 7 of R01 AI126914-01

—Figure 7 of R44 AI128983-01

—Figures 8A and 8B of R21 AI142068-01

• increased IFN-γ expression in the immune cells of mice injected with human recombinant vaults containing HPV peptides in Figure 3 of R43 CA228629-01
• dose-dependent increase in IFN-γ expression in the immune cells of mice injected with human recombinant vaults containing HIV Gag peptides in Figure 8 of P01 AI131294-01 and Figure 8C of R21 AI142068-01
• IFN-γ expression in the immune cells of mice administered intranasally with human recombinant vaults containing HPV peptides in Figure 10 of R21 AI131451-01A1 and Figure 10 of R21 AI142068-01
• IFN-γ expression in the immune cells of mice administered orally with human recombinant vaults containing HIV Gag peptides in Figure 11 of R21 AI131451-01A1 and Figure 9 of R21 AI142068-01
• IFN-γ expression in the immune cells of mice immunized subcutaneously with increasing doses of human recombinant vaults containing HIV Gag-1 spanning peptides in Figure 14 of R01 AI126914-01 and Figure 13 of R44 AI128983-01

Dr. Jiang entered into a Voluntary Settlement Agreement (Agreement) and voluntarily agreed to the following:

(1) Respondent will have her research supervised for a period of three (3) years beginning on July 22, 2022 (the “Supervision Period”). Prior to the submission of an application for PHS support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity in PHS-supported research, Respondent will submit a plan for supervision of Respondent's duties to ORI for approval. The supervision plan must be designed to ensure the integrity of Respondent's research. Respondent will not participate in any PHS-supported research until such a supervision plan is approved by ORI. Respondent will comply with the agreed-upon supervision plan.

(2) The requirements for Respondent's supervision plan are as follows:

i. A committee of two senior faculty members at the institution who are familiar with Respondent's field of research, but not including Respondent's supervisor or collaborators, will provide oversight and guidance for a period of three (3) years from the effective date of this Agreement. The committee will review Respondent's primary data on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates and Respondent's compliance with appropriate research standards and ( printed page 48036) confirming the integrity of Respondent's research.

ii. The committee will conduct an advance review of each application for PHS funds, or report, manuscript, or abstract involving Respondent's research. The review will include a discussion with Respondent of the primary data represented in those documents and will include a certification to ORI that the Respondent's data presented in the proposed application, report, manuscript, or abstract are supported by the research record.

(3) During the Supervision Period, Respondent will ensure that any institution employing her submits, 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 and not plagiarized in the application, report, manuscript, or abstract.

(4) If no supervision plan is provided to ORI, Respondent will provide certification to ORI at the conclusion of the Supervision Period that her participation was not proposed on a research project for which an application for PHS support was submitted and that she has not participated in any capacity in PHS-supported research.

(5) During the Supervision Period, Respondent will exclude herself voluntarily from serving in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee.

87 FR 48034