[Federal Register Volume 87, Number 151 (Monday, August 8, 2022)]
[Notices]
[Pages 48187-48188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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.
     R01 AI159898-01, ``Effect of latent TB infection on 
immunity to M. tuberculosis reinfection,'' submitted to NIAID, NIH, on 
June 25, 2020.
     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:
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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