Notice2022-16946
Findings of Research Misconduct
Primary source
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Published
August 8, 2022
Issuing agencies
Health and Human Services Department
Abstract
Findings of research misconduct have been made against Deepak Kaushal, Ph.D. (Respondent), Professor and Director, Southwest National Primate Research Center, Host Pathogen Interactions Program, Texas Biomedical Research Institute (TBRI). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants U19 AI111211, R01 AI111943, R01 AI123047, R01 AI134240, K24 AI058609, and K24 AI114444, and Office of the Director, NIH, grants P51 OD011104 and P51 OD011133. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on July 22, 2022, and are detailed below.
Full Text
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<title>Federal Register, Volume 87 Issue 151 (Monday, August 8, 2022)</title>
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[Federal Register Volume 87, Number 151 (Monday, August 8, 2022)]
[Notices]
[Pages 48187-48188]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16946]
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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 Deepak
Kaushal, Ph.D. (Respondent), Professor and Director, Southwest National
Primate Research Center, Host Pathogen Interactions Program, Texas
Biomedical Research Institute (TBRI). Respondent engaged in research
misconduct in research supported by U.S. Public Health Service (PHS)
funds, specifically National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of Health (NIH), grants U19
AI111211, R01 AI111943, R01 AI123047, R01 AI134240, K24 AI058609, and
K24 AI114444, and Office of the Director, NIH, grants P51 OD011104 and
P51 OD011133. The administrative actions, including supervision for a
period of one (1) year, 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:
Deepak Kaushal, Ph.D., Texas Biomedical Research Institute: Based
on the report of an inquiry conducted by TBRI, Respondent's admission,
and additional analysis conducted by ORI in its oversight review, ORI
found that Dr. Deepak Kaushal, Professor and Director, Southwest
National Primate Research Center, Host Pathogen Interactions Program,
TBRI, engaged in research misconduct in research supported by PHS
funds, specifically NIAID, NIH, grants U19 AI111211, R01 AI111943, R01
AI123047, R01 AI134240, K24 AI058609, and K24 AI114444, and Office of
the Director, NIH, grants P51 OD011104 and P51 OD011133.
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, and/or recklessly falsifying and fabricating
the experimental methodology to demonstrate results obtained under
different experimental conditions that were included in the following
one (1) published paper and two (2) grant applications submitted for
PHS funds:
<bullet> Isoniazid and Rifapentine Treatment Eradicates Persistent
Mycobacterium tuberculosis in Macaques. Am J Respir Crit Care Med. 2020
Feb 15;201(4):469-77; doi: 10.1164/rccm.201903-0646OC (hereafter
referred to as ``Am J Respir Crit Care Med 2020''). Retraction in: Am J
Respir Crit Care Med. 2021 Apr 15;203(8):1045; doi: 10.1164/
rccm.v203retraction1.
<bullet> R01 AI159898-01, ``Effect of latent TB infection on
immunity to M. tuberculosis reinfection,'' submitted to NIAID, NIH, on
June 25, 2020.
<bullet> R01 AI147947-01A1, ``Effect of prior latent TB infection
on immune responses to M. tuberculosis,'' submitted to NIAID, NIH, on
July 18, 2019.
Specifically, ORI found that Respondent knowingly, intentionally,
or recklessly:
<bullet> Falsified and fabricated the numbers for treated and
untreated non-human primates (NHP) used in the study. The experimental
design in Am J Respir Crit Care Med 2020 falsely stated that seven NHPs
were treated with 3HP (i.e., a treatment regimen constituting of twelve
once-weekly doses of 15 mg/kg isoniazid [INH] and 15 mg/kg rifapentine
[RPT]) and another seven NHPs were untreated controls, when instead a
total of eight NHPs were treated with INH and RPT and six NHPs were
untreated controls.
<bullet> Falsified and fabricated the number of weekly doses of INH
and RPT treatment administered to NHPs in the study. The experimental
design in Am J Respir Crit Care Med 2020 falsely stated that seven NHPs
were treated with 3HP, when instead the NHPs were treated with a
variable number of INH and RPT doses that do not conform to the 3HP
regimen.
<bullet> Falsified and fabricated the time interval between
mycobacterium (Mtb) exposure and the first dose of INH and RPT
treatments that were administered to NHPs in the study. The
experimental design in Am J Respir Crit Care Med 2020 falsely stated
that seven NHPs were treated with 3HP beginning in Week 16-18 after Mtb
infection, when instead the treated NHPs received the first dose of INH
and RPT treatment at different time points.
<bullet> Falsified and fabricated the time interval between the
last weekly doses of INH and IPT treatment and infection with simian
immunodeficiency virus (SIV). The experimental design in Figure 3A of
Am J Respir Crit Care Med 2020 falsely stated that after treatment with
weekly INH and RPT for three months, NHPs were rested for one month
before coinfection with SIV, when instead the treated NHPs were
infected with SIV either on the same day as the last dose of INH and
RPT treatment or at a different time point.
<bullet> Included survival kinetics data from the falsified 3HP
treatment in Figure 1G of Am J Respir Crit Care Med 2020 as Figure 5 of
R01 AI159898-01 to demonstrate the efficacy of 3HP treatment against
reactivation of latent Mtb infection in NHPs post SIV infection.
<bullet> Included bacterial persistence and burden data from the
falsified 3HP treatment in Figures 2A, 2B, and 2C of Am J Respir Crit
Care Med 2020 as Figure 6C of R01 AI159898-01 and Figure 2 of R01
AI147947-01A1 to represent the efficacy of 3HP treatment in reducing
Mtb burden in NHPs post SIV infection.
<bullet> Included pulmonary pathology data from the falsified 3HP
treatment in Figures 3A and 3B of Am J Respir Crit Care Med 2020 as
Figures 6A and 6B, respectively, of R01 AI159898-01 to represent the
efficacy of 3HP treatment against reactivation of latent Mtb infected
NHPs post SIV infection.
<bullet> Included clinical parameters from the falsified 3HP
treatment in Figure 1 of Am J Respir Crit Care Med 2020 as Figure 1 of
R01 AI147947-01A1 to present clinical correlates of latent Mtb
infection and SIV induced reactivation under 3HP treatment.
<bullet> Included pulmonary pathology data from the falsified 3HP
treatment in Figure 3 of Am J Respir Crit Care Med 2020 as Figure 3 of
R01 AI147947-01A1 to represent efficacy of 3HP treatment in reducing
lung pathology due to reactivation of latent Mtb infection in NHPs post
SIV infection.
<bullet> Included untreated NHP's lung tissue immunohistochemistry
image representing CD3-positive T-cell staining from Figure 4B of Am J
Respir Crit Care Med 2020 as Figure 6A of R01 AI147947-01A1 to
represent CD3-positive T-cell staining in lung tissue of 3HP treated
NHPs.
[[Page 48188]]
Dr. Kaushal entered into a Voluntary Settlement Agreement
(Agreement) and voluntarily agreed to the following:
(1) Respondent will have his research supervised for a period of
one (1) year 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 2-3 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 one (1) year from the effective date of this
Agreement. The committee will review primary data from Respondent's
laboratory 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
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
PHS-supported research in which Respondent is involved. 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 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 him 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 his participation was not proposed on a research project
for which an application for PHS support was submitted and that he has
not participated in any capacity in PHS-supported research.
(5) During the Supervision Period, Respondent will exclude himself
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 3, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2022-16946 Filed 8-5-22; 8:45 am]
BILLING CODE 4150-31-P
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