[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49661-49662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: Findings of research misconduct have been made against Rahul 
Dev Jayant, Ph.D. (Respondent), Assistant Professor Pharmaceutical 
Sciences, School of Pharmacy, Texas Tech University Health Science 
Center (TTUHSC). Dr. Jayant engaged in research misconduct in research 
supported by U.S. Public Health Service (PHS) funds, specifically 
National Institute on Drug Abuse (NIDA), National Institutes of Health 
(NIH), grant R03 DA044877. The administrative actions, including 
supervision for a period of three (3) years, were implemented beginning 
on July 27, 2020, and are detailed below.

FOR FURTHER INFORMATION CONTACT: Elisabeth A. Handley, 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:
    Rahul Dev Jayant, Ph.D., Texas Tech University Health Science 
Center: Based on the report of an inquiry conducted by TTUHSC and 
additional analysis conducted by ORI in its oversight review, ORI found 
that Dr. Jayant, Assistant Professor Pharmaceutical Sciences, School of 
Pharmacy, TTUHSC, engaged in research misconduct in research supported 
by PHS funds, specifically NIDA, NIH, grant R03 DA044877.
    ORI found that Respondent engaged in research misconduct by 
intentionally plagiarizing, falsifying, and/or fabricating data 
included in the following grant applications submitted for PHS funds:
     R21 DA051845-01, ``DAT-CNS Organoid-Chip Model to 
Characterize the Effects of Buprenorphine on Fetal Neurodevelopment,'' 
submitted to NIDA, NIH, on October 16, 2019.
     R01 DA051894-01, ``Novel 3D Printed CNS-Organoid Chip 
Model to Elucidate HAND,'' submitted to NIDA, NIH, on November 12, 
2019.
     R21 DA052445-01, ``3D Printed Microfluidic Chip Cerebral 
Organoids (3D-MCCO) to Decode Neurodevelopmental Deficits with 
Oxycodone Exposure,'' submitted to NIDA, NIH, on February 10, 2020.
     R21 AA028877-01, ``3D Printed CNS-Organoid Chip Model to 
Identify Biomarkers for Prenatal Alcohol Exposure,'' submitted to the 
National Institute on Alcohol Abuse and Alcoholism (NIAAA), NIH, on 
February 13, 2020.
    ORI found that Respondent engaged in research misconduct by 
intentionally:
     Plagiarizing four (4) images of brain organoids and one 
(1) graph from Nat Protoc. 2014 Oct; 9(10):2329-40 (hereafter referred 
to as ``NP 2014'') without author attribution and including the 
plagiarized material in Figure 3iia-c of R21 DA051845-01, Figure 2iiia-
c of R01 DA051894-01, Figure 3iiia-c of R21 DA052445-01, Figure 3iiia-c 
of R21 AA028877-01, and the graph in Figure 2iv of R01 DA051894-01.
     Plagiarizing one (1) image of brain organoids from Nature 
Communications 2018 Oct 9; 9(1):4167 (hereafter referred to as ``NC 
2018'') without author attribution and including the plagiarized 
material in Figure 2iiid of R01 DA051894-01.
     Falsifying and fabricating three (3) figures representing 
experiments measuring caspase3 expression in human brain organoids by 
reusing data from one experiment to represent different experimental 
treatments in Figure 4Bii of R21 DA051845-01, Figure 4iv of R21 
DA052445-01, and Figure 3iii of R21 DA051894-01.
     Fabricating nine (9) bar graphs representing experiments 
measuring gene expression in control and experimental samples of human 
brain organoids treated with drugs of abuse in Figures 2i and 3i-iii of 
R21 DA051894-01, Figures 3ii, 4Ai-ii, and 4Bii of R21 AA028877-01, 
Figures 3ii and 4i-iii of R21 DA052445-01, and Figures 4A, 4Bi, and 5 
of R21 DA051845-01.
    Specifically, ORI found that Respondent intentionally:
     Plagiarized confocal images of immuno-stained samples of 
human brain organoids from Figure 4 of NP 2014, and the plagiarized 
images were cropped, rotated, contrast enhanced and labeled with scale 
bars in:

--Figure 3iia-c in R21 DA051845-01
--Figure 2iiia-c in R01 DA051894-01
--Figure 3iiia-c in R21 DA052445-01
--Figure 3iiia-c in R21 AA028877-01

     Plagiarized confocal images of immuno-stained samples of 
human brain organoids from Figure 1e of NC 2018 in Figure 2iiid in R01 
DA051894-01. The plagiarized image was cropped and rotated and the 
contrast was altered.
     Plagiarized the graph in Figure 2iv in R01 DA051894-01 
representing measurements of gene expression and associated statistics 
in cultured human brain organoids. The source of the plagiarized graph 
is unknown.
     Plagiarized the graph in Figure 2iv in R01 DA051894-01 
representing measurements of gene expression and associated statistics 
in cultured human brain organoids. The source of the plagiarized graph 
is unknown.
     Falsified and fabricated control and experimental data 
representing measurements of caspase3 mRNA expression in human brain 
organoids treated with drugs of abuse. The identical images were 
falsely relabeled to represent different experimental treatments that 
were never done. The identical panels are:

--Figure 4Bii, labeled as ``Buprenorphine (5 [micro]M),'' in R21 
DA051845-01
--Figure 4iv, labeled as ``Oxy 10 [micro]M,'' in R21 DA052445-01
--Figure 3iii, labeled as ``Meth-10[micro]M,'' in R21 DA051894-01

     Falsified Figure 4Bi in R21 AA028877-01 to represent 
control and experimental data measuring neurite outgrowth in cultured 
human neurons treated with ethanol. The panels in Figure 4Bi in R21 
DA051894-01, labeled as control or treated with 10ng/ml Tat for 1 or 7 
days, are identical to those in Figure 4Bi in R21 AA028877-01, which 
were falsely relabeled as control or treated with 10 or 40 mM EtOH.
     Fabricated quantitative data and associated statistics 
representing measurements of gene expression levels in cultured human 
brain organoids over time or treated with drugs of abuse.
    The fabricated bar graphs are:

--Figures 2i and 3i-iii in R21 DA051894-01
--Figures 3ii, and 4Ai-ii, and 4Bii in R21 AA028877-01
--Figures 3ii and 4i-iii in R21 DA052445-01
--Figures 4A, Bi, and 5 in R21 DA051845-01

    Dr. Jayant entered into a Voluntary Settlement Agreement and agreed 
to the following:
    (1) Respondent agreed to have his research supervised for a period 
of three (3) years beginning on July 27, 2020. Respondent agreed that 
prior to the submission of an application for PHS support for a 
research project on which Respondent's participation is proposed

[[Page 49662]]

and prior to Respondent's participation in any capacity on PHS-
supported research, Respondent shall ensure that a plan for supervision 
of Respondent's duties is submitted to ORI for approval. The 
supervision plan must be designed to ensure the scientific integrity of 
Respondent's research contribution. Respondent agreed that he 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) 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 three (3) years from the effective date of the 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 any PHS grant 
applications (including supplements, resubmissions, etc.), manuscripts 
reporting PHS-funded research submitted for publication, and abstracts. 
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/publication is 
supported by the research record.
    (3) Respondent agreed that for a period of three (3) years 
beginning on July 27, 2020, any institution employing him shall submit, 
in conjunction with each application of 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.
    (4) If no supervisory plan is provided to ORI, Respondent agreed to 
provide certification to ORI at the conclusion of the supervision 
period that he has not engaged in, applied for, or had his name 
included on any application, proposal, or other request for PHS funds 
without prior notification to ORI.
    (5) Respondent agreed to exclude himself 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 July 27, 
2020.

    Dated: August 11, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2020-17800 Filed 8-13-20; 8:45 am]
BILLING CODE 4150-31-P