[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Pages 51037-51039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18137]


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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 Anil K. 
Jaiswal, Ph.D. (Respondent), former professor, Department of 
Pharmacology, University of Maryland at Baltimore, School of Medicine 
(UMB). Dr. Jaiswal engaged in research misconduct in research supported 
by U.S. Public Health Service (PHS) funds, specifically National Cancer 
Institute (NCI), National Institutes of Health (NIH), grants R01 
CA062483 and R01 CA081057; National Institute of Environmental Health 
Sciences (NIEHS), NIH, grants R01 ES007943, R01 ES012265, and R01 
ES021483; and National Institute of General Medical Sciences (NIGMS), 
NIH, grant R01 GM047466. The administrative actions, including 
debarment for a period of three (3) years, were implemented beginning 
on July 21, 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:
    Anil K. Jaiswal, Ph.D., University of Maryland at Baltimore, School 
of Medicine: Based on an investigation conducted by UMB and additional 
analysis conducted by ORI in its oversight review, ORI found that Dr. 
Anil K. Jaiswal, former professor, Department of Pharmacology, UMB, 
engaged in research misconduct in research supported by PHS funds, 
specifically NCI, NIH, grants R01 CA062483 and R01 CA081057; NIEHS, 
NIH, grants R01 ES007943, R01 ES012265, and R01 ES021483; and NIGMS, 
NIH, grant R01 GM047466. ORI found that Respondent intentionally, 
knowingly, or recklessly: (a) Used random blank background sections of 
film or empty boxes to falsely represent or fabricate western blot 
analyses; (b) used manipulated images to generate and report falsified 
data in figures; and (c) used mislabeled images to falsely report data 
in figures. Respondent's research misconduct occurred in the following 
four (4) funded PHS grant applications, four (4) unfunded PHS grant 
applications, and six (6) PHS-supported published papers:
     NCI, NIH grant application R01 CA081057-11, Mechanisms of 
Bioreductive Drugs Activation (unfunded)
     NIEHS, NIH grant application R01 ES007943-10, Prevention 
of Quinone Toxicity and Mutagenicity (funded).
     NIEHS, NIH grant application R01 ES007943-15, Prevention 
of Quinone Toxicity and Mutagenicity (unfunded).

[[Page 51038]]

     NIEHS, NIH grant application R01 ES007943-15A1, Prevention 
of Quinone Toxicity and Mutagenicity (funded).
     NIEHS, NIH grant application R01 ES012265-07, Role and 
Regulation of INrf2 (funded).
     NIEHS, NIH grant application R01 ES021483-01, Quinone 
Oxidoreductases and Mammary Toxicity/Carcinogenicity (unfunded).
     NIGMS, NIH grant application R01 GM047466-20, Regulation 
of NAD(P)H:Quinone Oxydoreductases (unfunded).
     NIGMS, NIH grant application R01 GM047466-20A1, Regulation 
of NAD(P)H:Quinone Oxydoreductases (funded).
     Overlapping signal sequences control nuclear localization 
and endoplasmic reticulum retention of GRP58. Biochem Biophys Res 
Commun. 2008 Dec 12;377(2):407-12 (hereafter referred to as ``BBRC 
2008''). Retraction in: Biochem Biophys Res Commun. 2018 Jun 27; 
501(3):826.
     Disruption of the NAD(P)H:quinone oxidoreductase 1 (NQO1) 
gene in mice causes myelogenous hyperplasia. Cancer Res 2002 Jun 
1;62(11):3030-6 (hereafter referred to as ``Cancer Res 2002''). 
Retraction in: Cancer Res 2018 Nov 15;78(22):6526.
     Deficiency of NRH:quinone oxidoreductase 2 increases 
susceptibility to 7,12-dimethylbenz(a)anthracene and benzo(a)pyrene-
induced skin carcinogenesis. Cancer Res 2004 Sep 1;64(17):5925-8 
(hereafter referred to as ``Cancer Res 2004'').
     Nuclear import and export signals in control of Nrf2. J 
Biol Chem. 2005 Aug 12;280(32):29158-68; Epub 2005 May 17 (hereafter 
referred to as ``JBC 2005''). Retraction in: J Biol Chem. 2017 Feb 
3;292(5):2052.
     Quinone oxidoreductases in protection against myelogenous 
hyperplasia and benzene toxicity. Chem Biol Interact. 2005 May 30;153-
154:147-57 (hereafter referred to as Chem Biol Interact. 2005'').
     Low and high dose UVB regulation of transcription factor 
NF-E2-related factor 2. Cancer Res 2006 Sep 1;66(17):8421-9 (hereafter 
referred to as ``Cancer Res 2006''). Retraction in: Cancer Res 2018 Nov 
1;78(21):6346.
    Specifically, ORI found by a preponderance of the evidence that 
Respondent engaged in research misconduct by intentionally, knowingly, 
or recklessly:
     Using a random blank background section of a film for PHS 
grant application R01 CA081057-11, Figure 8D (top panel), to falsely 
report that human kidney carcinoma 293 expressing vector (293-V) did 
not express the Flag-Nrf2 protein, regardless of treatment condition 
(control, tetracycline, tetracycline + tert-butyl hydroquinone).
     using a random blank background section of a film for PHS 
grant application R01 CA081057-11, Figure 9B (right-side, top panel), 
to falsely report that human kidney carcinoma 293 expressing vector 
(293-V) did not express the Flag-Nrf2 protein, regardless of treatment 
condition (control, etoposide, tetracycline + etoposide, tetracycline + 
tert-butyl hydroquinone + etoposide).
     using empty boxes drawn in PowerPoint in PHS grant 
application R01 GM047466-20A1, Figure 5 (left-side, third and fourth 
LDH panels), to falsify or fabricate the absence of LDH protein 
expression in human fibroblast and mouse skin keratinocytes when 
exposed to 0 to 20 J/m\2\ UVB.
     using empty boxes drawn in PowerPoint in Cancer Res 2006, 
Figures 2A (middle panel on left; and lower panel on right) and 2D 
(lower panel), to falsely show that there was an absence of Lamin B and 
LDH protein expression.
     using a manipulated image in which the background was 
digitally added to falsely show the expression of p53, in wild type and 
NQO2-/- mice skin exposed to acetone, 800 nmol of 
benzo(a)pyrene (``BP800'') or 1600 nmol of benzo(a)pyrene (``BP1600'') 
dissolved in acetone in PHS grant application R01 ES007943-10, Figure 
10 (right side, top panel); in PHS grant application R01 ES007943-15, 
Figure 4C (top panel); and in Cancer Res 2004, Figure 2 (top panel).
     using an image that had been cropped, vertically 
stretched, and horizontally flipped to falsely show that wild-type 
mouse keratinocytes that express NQO1 were used in PHS grant 
application R01 ES007943-15, Figure 9A (seventh panel on left), and PHS 
grant application R01 ES007943-15A1, Figure 6A (seventh panel on the 
left).
     using an image that masked bands in BBRC 2008, Figures 1D 
(top panel on left) and 1E (bottom panel on left), to falsely report 
figures, which showed:
--That in HCT116 cells transfected with NLS deficient GRP58DNLS-V5, the 
nuclear localization of GRP58 is completely abrogated when in fact the 
contrast was changed to conceal the expression
--the effect of putative NLS sequence on nuclear localization of GRP58 
in HCT116 cells transfected with pcDNA-V5 plasmids for GRP58-WT or 
GRP58-NLS K-A mutant when in fact blots showing the control condition, 
Lamin B, were concealed by changing the contrast
     using an image that had been horizontally flipped and 
stretched, with contrast enhanced to falsify Cyp1A1 data in BBRC 2008, 
Figure 4A (bottom panel on left), to falsely report a figure that 
showed HCT116 cells transfected with pcDNA-GRP58-WT-V5 or pcDNA-GRP58-
[Delta]ER-V5 showed increased expression in the endoplasmic reticulum 
when the original data showed increased expression in the cytosolic 
fraction.
     using a vertically flipped image in BBRC 2008, Figure 4B 
(top panel), to falsely report a figure that showed HCT116 cells 
transfected with GRP58 NLS/ER DD (combined deletion of NLS and ER 
regions) is not expressed in the endoplasmic reticulum or the nuclear 
fraction but only in the cytosolic fraction.
     using a manipulated image in which the contrast and 
brightness had been enhanced in JBC 2005, Figure 4B, to falsely report 
a figure that showed reduced protein expression of LDH and Lamin B.
     using the image in Figure 9 (top right) in PHS grant 
application R01 ES012265-07 to falsely represent reverse 
immunoprecipitation of Hepa-1 cell extract with anti-INrf2 and anti-
PGAM5L antibodies and reusing the same image, after being flipped 
horizontally, in Figure 12 (top right) of the same application to 
falsely represent the same experiment as with anti-Flag and pICln 
antibodies.
     falsifying reported results in Figure 9 (upper panel) in 
PHS grant application R01 ES021483-01 as representing in vitro 
translation of two proteins (BRCA1 and NQO1), showing that NQO1 
stabilizes BRCA1 against 20S proteasomal degradation, by falsely using 
bands labeled NQO1 from a cell lysate experiment on the original film, 
flipping them horizontally, enhancing the contrast to obscure one band 
(BRCA1+20S), and falsely relabeling the resulting panel as BRCA1.
     using bands labeled as [beta]-actin from a cell lysate 
experiment on the original film, cutting out two of the bands, falsely 
labeling them as having been incubated with 20S + NQO1 or 20S + NQO1 + 
NADH, and falsely relabeling the resulting panel as NQO1 in PHS grant 
application R01 ES021483-01, Figure 9 (lower panel).
     using a sample with a molecular weight of 80-85kD to 
falsely represent P-Akt-Thr308, which should have a molecular weight of 
60kD, in PHS grant applications R01 GM047466-20 and R01 GM047466-20A1, 
Figure 4 (first panel).

[[Page 51039]]

     using samples appearing in two different films, one 
labeled as PP2A (with a molecular weight of 75kD) and the other labeled 
as Akt S473 to falsely represent PP2A (with a molecular weight of 35kD) 
in PHS grant applications R01 GM047466-20 and R01 GM047466-20A1, Figure 
4 (sixth panel).
     using protein bands from a film dated 8/25/2000 showing 
the expression of NQO1 in wild-type mouse liver and bone marrow to 
falsely represent a figure labeled instead as the expression of NQO1 in 
the bone marrow of wild type and NQO1 heterozygous mice in Cancer Res 
2002, Figure 1A, and Chem Biol Interact. 2005, Figure 2B.
     using a single blot of protein bands to falsely represent 
western blots exhibiting the expression of three different proteins 
(p53, p73, and tubulin) in Cancer Res 2002, Figure 7A.
    Dr. Jaiswal entered into a Voluntary Exclusion Agreement 
(Agreement) and agreed to the following:
    (1) Respondent agreed to exclude himself voluntarily for a period 
of three (3) years beginning on July 21, 2020, from any contracting or 
subcontracting with any agency of the United States Government and from 
eligibility for or involvement in nonprocurement programs of the United 
States Government referred to as ``covered transactions'' pursuant to 
HHS's Implementation (2 CFR part 376) of OMB Guidelines to Agencies on 
Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively 
the ``Debarment Regulations'');
    (2) 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 21, 
2020; and
    (3) as a condition of the Agreement, Respondent will request that 
the following papers be corrected or retracted in accordance with 42 
CFR 93.407(a)(1) and 93.411(b):
 Cancer Res 2004 Sep 1;64(17):5925-8
 Chem Biol Interact. 2005 May 30;153-154:147-57
    Respondent will copy ORI and the Research Integrity Officer at UMB 
on the correspondence.

    Dated: August 14, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2020-18137 Filed 8-18-20; 8:45 am]
BILLING CODE 4150-31-P