[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34357-34358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12800]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Ricky Malhotra, Ph.D., University of Michigan and University of 
Chicago: Based on the Respondent's admission to committing research 
misconduct at the University of Michigan (UM) and subsequently at the 
University of Chicago (UC), the reports of separate investigations 
conducted by UM and UC, and additional analysis conducted by ORI in its 
oversight review, ORI found that Dr. Ricky Malhotra, former Research 
Assistant Professor, Department of Internal Medicine, UM, from 2005-
2006, and Research Assistant Professor, Department of Surgery, UC, from 
2007-2011, engaged in research misconduct in research supported by 
National Heart, Lung, and Blood Institute (NHLBI), National Institutes 
of Health (NIH), grants K08 HL081472 and R01 HL107949.
    ORI found that falsified and/or fabricated data were included in 
the following three (3) NIH grant applications, one (1) NIH grant 
progress report, one (1) publication, seven (7) presentations, and one 
(1) image file:

 R03 AG029508-01
 R21 AG030361-01
 R01 HL102405-01
 K08 HL081472-05 Progress Report
 J Biol Chem. 285(18):13748-60, 2010 Apr 30 (hereafter referred 
to as ``JBC 2010'')
 Presentation: Autophagy Pathway.ppt, MKK4 expression after 
UV.ppt, Oct PPt.ppt, RicDec.ppt, Ricky Presentation 06.ppt, Ricky 
STC.ppt, and RM.ppt
 Image file: Final LC 3.jpg

    ORI found that Respondent reused and falsely relabeled Western blot 
gel images, falsified the related densitometry measurements based on 
the falsified Western blots, and falsified and/or fabricated data for 
experiments that were not performed. Respondent continued this 
falsification at UC, after the UM research misconduct investigation was 
completed. Specifically:
     While at UM, Respondent falsified and/or fabricated images 
in R03 AG029508-01 and three (3) presentations, where:
    [ssquf] R03 AG029508-01, Figure 2, represented Western blots for 
phosphorylated p53 (Ser15) and [beta]-actin expression in normal and 
Snell dwarf mice fibroblasts (mN/SF) treated with the DNA alkylating 
agent methyl methanesulfonate (MMS), when the same images were 
duplicated to represent different proteins and treatments in the 
presentations Autophagy Pathway.ppt and RM.ppt.
    [ssquf] R03 AG029508-01, Figure 3, represented Western blots for 
p16\Ink4a\ and [beta]-actin expression in mN/SF, when the same images 
were duplicated to represent different proteins and treatments in the 
presentations Autophagy Pathways.ppt, RicDec.ppt, and RM.ppt.
     While at UM, Respondent fabricated data in R21 AG030361-01 
and supporting data for the grant application in the research record, 
where:
    [ssquf] R21 AG030361-01, Figure 2, represented a Western blot for 
phosphorylated c-Jun-N-terminal kinase (JNK) expression in mN/SF 
exposed to cadmium, when the experiment was not performed.
    [ssquf] The research record contained ninety (90) Western blot 
images and ninety (90) densitometry measurement files for 45 
experiments that examined phosphorylated JNK or Mitogen-activated 
protein kinase 4 (MMK4) expression in mN/SF exposed to UV light, 
H2O2, cadmium, or anisomycin, when the 
experiments were not performed.
    [ssquf] The research record contained densitometric analyses for an 
additional twenty-eight (28) experiments that examined phosphorylated 
JNK or MMK4 expression in mN/SF exposed to UV light, 
H2O2, cadmium, or anisomycin, when the 
quantifications were based on experiments that were not performed.
     While at UM, Respondent falsified and/or fabricated 
Western blots for phosphorylated and total Rac1/cdc42 expression in mN/
SF, total JNK expression in mN/SF treated with anisomycin, 
phosphorylated JNK expression in Snell dwarf mice fibroblasts treated 
with cadmium, [beta]-actin expression in mN/SF, [beta]-actin expression 
in Snell dwarf mice fibroblasts treated with or without MMS, [beta]-
actin expression in normal mice fibroblasts treated with cadmium, and 
[beta]-actin expression in mN/SF treated with 
H2O2 in the presentations Autophagy Pathway.ppt, 
Oct PPt.ppt, RicDec.ppt, Ricky Presentation 06.ppt, Ricky STC.ppt, and 
RM.ppt, and the image file Final LC 3.jpg, when the images were 
duplicated and falsely relabeled Western blots of unrelated 
experiments.
     While at UM, Respondent falsified twenty-four (24) Western 
blots for phosphorylated JNK or MMK4 expression in mN/SF exposed to UV 
light, H2O2, cadmium, or anisomycin in the seven 
(7) presentations and twenty-six (26) data files in the research 
record, when the images were duplicated and falsely relabeled Western 
blots of unrelated experiments.
     While at UC, Respondent falsified and/or fabricated 
Western blots by using images from unrelated experiments and the 
related densitometric analyses that were based on falsified Western 
blots in the following:
    [ssquf] R01 HL102405-01 for:

--Figure 1A for phosphorylated Rhodopsin (Rho) expression in neonatal 
rat ventricular cardiac myocytes (NRVCM) subjected to stimulation with 
Angiotension II (Ang II)

[[Page 34358]]

--Figure 1A for G protein-coupled receptor kinase-2 (GRK2) expression 
in NRVCM subjected to cyclical mechanical stretch
--Figure 1B for densitometric analysis of GRK2 activity
--Figure 2A for phosphorylated Rho and GRK2 expression in NRVCM 
subjected to mechanical stretch
--Figure 2B for densitometric analysis of GRK2 activity
--Figure 3A for phosphorylated Rho expression in NRVCM after mechanical 
stretch and treatment with protein kinase C (PKC) inhibitor 
chelerythrine (lanes 5 and 6)
--Figure 3B for densitometric analyses of GRK2 activity after PKC 
inhibition via chelerythrine treatment

    [ssquf] K08 HL081472-05 Progress Report for:

--Figure 1A for phosphorylated Rho and GRK2 expression in NRVCM 
subjected to mechanical stretch
--Figure 1B for densitometric analyses of GRK2 activity after PKC 
inhibition via chelerythrine treatment

    [ssquf] JBC 2010 for:

--Figure 1B for phosphorylated Rho expression in NTVCM subjected to 
stimulation with Ang II
--Figure 1B for GRK2 expression in NRVCM subjected to cyclical 
mechanical stretch panel
--Figure 1C for densitometric analysis of GRK2 activity
--Figure 2A for phosphorylated Rho expression in NRVCM after mechanical 
stretch and treatment with the Ang II type 1 (AT1) receptor 
antagonist Irbesartan (lanes 5 and 6)
--Figure 2B for densitometric analyses of GRK2 activity after PKC 
inhibition via Irbesartan treatment
--Figure 4C for phosphorylated Rho and GRK2 expression in NRVCM 
subjected to mechanical stretch
--Figure 4D for densitometric analysis of GRK2 activity after RNAi 
treatment

    Dr. Malhotra has entered into a Voluntary Settlement Agreement with 
ORI, in which he voluntarily agreed to the administrative actions set 
forth below:
    (1) Respondent agreed that he had no intention in applying for or 
engaging in U.S. Public Health Service (PHS)-supported research or 
otherwise working with PHS. However, if within five (5) years of the 
effective date of the Agreement (May 6, 2016), Respondent receives or 
applies for PHS support, Respondent agreed to have his research 
supervised for a period of ten (10) years beginning on the date of his 
employment in a position in which he receives or applies for PHS 
support and to notify his employer/institution(s) of the terms of this 
supervision.
    (2) Respondent certified that he is not currently engaged in or 
receiving PHS support. Respondent agreed that prior to the submission 
of an application for PHS support for a research project on which the 
Respondent's participation is proposed and prior to the 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 
as outlined below. 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.
    (3) The requirements for Respondent's supervision plan are as 
follows:
    i. A committee of senior faculty members and officials 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 ten (10) years. The committee will review 
primary data for Respondent's PHS-supported research on a quarterly 
basis setting forth the committee meeting dates, 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 
application (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 
that the data presented in the proposed application/publication is 
supported by the research record.
    (4) If within five (5) years from the effective date of the 
Agreement, Respondent receives or applies for PHS support, Respondent 
agreed that for a period of ten (10) years beginning on the date of his 
employment that any institution employing him shall submit, in 
conjunction with each application for PHS funds, or report, manuscript, 
or abstract involving PHS-supported research in which Respondent is 
involved, a report and certification to ORI at six (6) month intervals 
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.
    (5) If no supervisory plan is provided to ORI, Respondent agreed to 
provide certification to ORI on a quarterly basis for a period of five 
(5) years, beginning on May 6, 2016, that he has not engaged in, 
applied for, or had his name included on any application, proposal, or 
other request for PHS funds made available through grants, subgrants, 
cooperative agreements, contracts, subcontracts, supplements, awards, 
fellowships, projects, programs, small business technology transfer 
(STTR) and small business innovation research (SBIR) programs, 
conferences, meetings, centers, resources, studies, and trials, without 
prior notification to ORI.
    (6) 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 five (5) years, beginning on May 6, 
2016.
    (7) As a condition of the Agreement, Respondent agreed to the 
retraction of JBC 2010.

FOR FURTHER INFORMATION CONTACT:  Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8200.

Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2016-12800 Filed 5-27-16; 8:45 am]
 BILLING CODE 4150-31-P