[Federal Register Volume 87, Number 150 (Friday, August 5, 2022)]
[Notices]
[Pages 48034-48036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16867]


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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: Findings of research misconduct have been made against Janina 
Jiang, M.D., Ph.D. (Respondent), former Assistant Researcher in the 
Department of Pathology & Laboratory Medicine at the David Geffen 
School of

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Medicine, University of California, Los Angeles (UCLA). Respondent 
engaged in research misconduct in research included in grant 
applications submitted for U.S. Public Health Service (PHS) funds, 
specifically R43 CA228629-01 submitted to the National Cancer Institute 
(NCI), National Institutes of Health (NIH), UL1 TR000124 submitted to 
the National Center for Advancing Translational Sciences (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 the National Institute of Allergy and 
Infectious Diseases (NIAID), NIH. The administrative actions, including 
supervision for a period of three (3) years, were implemented beginning 
on July 22, 2022, and are detailed below.

FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting 
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 
240, Rockville, MD 20852, (240) 453-8200.

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-[gamma] (IFN-
[gamma]) 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-[gamma] 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-[gamma] 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-[gamma] 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-[gamma] 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-[gamma] 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-[gamma] 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

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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.

    Dated: August 2, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2022-16867 Filed 8-4-22; 8:45 am]
BILLING CODE 4150-31-P