Findings of Research Misconduct, 51037-51039 [2020-18137]
Download as PDF
<![CDATA[
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Notices
document is immediately in effect, it
remains subject to comment in
accordance with FDA’s GGP regulation
and FDA will consider all comments
received and revise the guidance
document as appropriate
(§ 10.115(g)(3)).
On November 8, 1990, we issued an
interim rule that amended, in relevant
part, part 320 (21 CFR 320) by adding
a requirement to retain reserve samples
of drug products (that is, samples of the
drug products that were used to conduct
BA or BE studies) for a specified period
and, when specifically requested, to
release the reserve samples to us. The
interim rule was intended to help
ensure BE between generic drugs and
their reference listed drugs and to help
us investigate possible fraud in BA and
BE testing. After consideration of public
comments, we published a final rule in
the Federal Register on April 28, 1993
(58 FR 25918).
In the final rule, 21 CFR 320.38 and
320.63 require a new drug application
or abbreviated new drug application
applicant (or its CRO) to retain reserve
samples of the test article and reference
standard that were used in conducting
any in vivo BA and in vivo or in vitro
BE study that supports the approval of
an application or supplemental
application. Specifically, § 320.38(c)
requires these applicants (or their CROs)
to retain a quantity of the test article and
reference standard that were used in BA
or BE testing that is at least five times
the amount of product required for
release testing.
Section 320.38(c) requires that reserve
samples of the test article and reference
standard used in a BA or BE study are
of a sufficient quantity to perform five
times all of the release tests required in
the application or supplemental
application. Since the final rule was
issued in 1993, technological advances
in our ability to test these products have
led to test methods that are less
destructive and more sensitive, allowing
us to detect the identity and
composition of the test article and
reference standard with smaller
volumes of samples. Consistent with
these developments, FDA has received
communications from applicants and
CROs requesting to retain a lower
quantity of the reserve samples.
In light of these technological
advances, this guidance discusses the
conditions under which we do not
generally intend to take regulatory
action against an applicant or CRO that
retains an appropriate reduced quantity
of reserve samples of the test article and
reference standard that were used in its
BA or BE testing.
VerDate Sep<11>2014
16:34 Aug 18, 2020
Jkt 250001
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Compliance Policy
for the Quantity of Bioavailability and
Bioequivalence Samples Retained
Under 21 CFR 320.38(c).’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR parts 312 and 314 have been
approved under OMB control numbers
0910–0014 and 0910–0001, respectively.
The collections of information in part
320 for ‘‘Investigational New Drug
Safety Reporting Requirements for
Human Drug and Biological Products
and Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans’’ have been
approved under OMB control number
0910–0672. The recordkeeping
requirement for CGMP sample retention
in 21 CFR 211.170 has been approved
under OMB control number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: August 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17798 Filed 8–18–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
Anil K. Jaiswal, Ph.D. (Respondent),
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
51037
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) PHSsupported 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).
E:\FR\FM\19AUN1.SGM
19AUN1
jbell on DSKJLSW7X2PROD with NOTICES
51038
Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Notices
• 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 7,12dimethylbenz(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
VerDate Sep<11>2014
16:34 Aug 18, 2020
Jkt 250001
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 (leftside, 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/m2 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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-DER–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 antiPGAM5L 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 b-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).
E:\FR\FM\19AUN1.SGM
19AUN1
Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
• 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
VerDate Sep<11>2014
16:34 Aug 18, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–6:
Research Answers to NCI Provocative
Questions.
Date: September 28, 2020.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W124, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Eun Ah Cho, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, 7W124, Rockville, MD 20850,
240–276–6342, choe@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–2:
Research Answers to NCI Provocative
Questions.
Date: September 28, 2020.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W104, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: David G. Ransom, Ph.D.,
Chief, Scientific Review Officer, Special
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W104,
Rockville, MD 20850, 240–276–6351,
david.ransom@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Research
Projects in Cancer Systems Biology.
Date: October 9, 2020.
Time: 10:30 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W238, Rockville, MD 20850 (Telephone
Conference Call).
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
51039
Contact Person: Byeong-Chel Lee, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W238, Rockville, MD 20850, 240–
276–7755, byeong-chel.lee@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–9: NCI
Clinical and Translational R21 and Omnibus
R03 Review.
Date: October 15, 2020
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W640, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Saejeong J. Kim, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W640, Rockville, MD
20850, 240–276–7684, saejeong.kim@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Biospecimen Science Technologies for Basic
and Clinical Cancer Research.
Date: October 20, 2020.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W104, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: David G. Ransom, Ph.D.,
Chief, Scientific Review Officer, Special
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W104,
Rockville, MD 20850, 240–276–6351,
david.ransom@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–9:
Research Answers to NCI Provocative
Questions.
Date: October 27, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W116, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Klaus B. Piontek, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W116,
Rockville, MD 20850, 240–276–5413,
klaus.piontek@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–10:
NCI Clinical and Translational R21 and
Omnibus R03 Review.
Date: October 28, 2020.
Time: 9:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W238, Rockville, MD 20850 (Telephone
Conference Call).
E:\FR\FM\19AUN1.SGM
19AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
