81 FR 35785 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 81, Issue 107 (June 3, 2016)

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Karen M. D'Souza, Ph.D., University of Chicago: Based on the report of an investigation conducted by the University of Chicago (UC) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Karen M. D'Souza, former Research Professional Associate, Department of Surgery, UC, 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 one (1) funded NIH grant, two (2) publications, two (2) posters, and one (1) presentation:

[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35785-35786]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13072]


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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: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Karen M. D'Souza, Ph.D., University of Chicago: Based on the report 
of an investigation conducted by the University of Chicago (UC) and 
additional analysis conducted by ORI in its oversight review, ORI found 
that Dr. Karen M. D'Souza, former Research Professional Associate, 
Department of Surgery, UC, 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 one (1) funded NIH grant, two (2) publications, two (2) 
posters, and one (1) presentation:

 R01 HL107949-01
 J Biol Chem. 285(18):13748-60, 2010 Apr 30 (hereafter referred 
to as ``JBC 2010'')
 J Biol Chem. 286(17):15507-16, 2011 Apr 29 (hereafter referred 
to as ``JBC 2011'')
 Gordon Conference 2006 poster: ``Regulation of Myocardial 
[beta]-Adrenergic Receptor Signaling By Protein Kinase C'' (hereafter 
referred to as ``GC2006'')
 Huggins 2010 poster: G[alpha]q-mediated activation of GRK2 by 
mechanical stretch in cardiac myocytes; the role of protein kinase C'' 
(hereafter referred to as ``HP2010'')
 Cardiac Research Day 2009 presentation: ``Regulation of G 
protein-coupled receptor signaling by mechanical stretch in cardiac 
myocytes'' (hereafter referred to as ``CR2009'')

    ORI found that Respondent reused and falsely relabeled and/or 
falsely spliced Western blot images, falsified

[[Page 35786]]

the related densitometry measurements based on the falsified Western 
blots, and falsified and/or fabricated data for experiments that were 
not performed or from unrelated experiments.
    Specifically, Respondent falsified and/or fabricated data in the 
following:

 R01 HL107949-01 for:
[ssquf] Figure 1B for Western blots of [alpha]-smooth muscle actin 
([alpha]-SMA), Vimentin, Collagen I and Glyceraldehyde 3-Phosphate 
Dehydrogenase (GAPDH) expression in human cardiac fibroblasts isolated 
from failing left ventricles (HF) and non-failing heart controls (CF)
[ssquf] Figure 2A for Western blots of G protein-coupled receptor 
kinase-2 (GRK2) and GAPDH expression in HF and CF, and the related 
densitometric analysis
 JBC 2011 for:
[ssquf] Figure 1A for a Western blot of Vimentin expression in HF and 
CF, and the related densitometric analysis
[ssquf] Figures 1D and 2D for Western blots of GAPDH expression in HF 
and CF, and the related densitometric analyses
 JBC 2010 for:
[ssquf] Figure 7A for Western blots of phosphorylated Rhodopsin (Rho) 
and GRK2 expression in non-transgenic (NTG) (lanes 1-4) and Protein 
Kinase C[alpha] cardiac-specific activation (PKC[alpha]AC) transgenic 
(lanes 5-6) mice, and Figure 7B for the related densitometric analysis
 GC2006, Figure 7, HP2010, Figure 5, and CR2009, Slide 15 for:
[ssquf] Western blots of phosphorylated Rho and GRK2 expression in NTG 
and PKC[alpha]AC transgenic mice, and the related densitometric 
analysis
 HP2010 for:
[ssquf] Figure 5 for a Western blot of GRK2 expression in NTG and 
PKC[alpha]AC transgenic mice, and the related densitometric analysis

    Dr. D'Souza has entered into a Voluntary Settlement Agreement with 
ORI, in which she voluntarily agreed to the administrative actions set 
forth below:
    (1) Respondent agreed that for two (2) years beginning on May 6, 
2016, any institution employing her shall submit in conjunction with 
each application for U.S. Public Health Service (PHS) funds, or report, 
manuscript, or abstract involving PHS-supported research in which 
Respondent is involved, a supervision plan to ORI. 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 Respondent's participation in any capacity on PHS-
supported research, any institution employing her shall ensure that a 
plan for supervision of her duties is submitted to ORI for approval. 
The supervision plan must be designed to ensure the scientific 
integrity of Respondent's PHS-supported research contribution and 
include the specific elements as outlined below. Respondent agreed that 
she 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 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 two (2) years beginning on May 6, 2016. The 
committee will review PHS-supported primary data from Respondent and 
submit a report to ORI at six (6) month intervals, setting forth the 
committee meeting dates, Respondent's compliance with appropriate 
research standards, and confirming the integrity of Respondent's PHS-
supported 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.
    (3) Respondent agreed that for two (2) years beginning on May 6, 
2016, any institution employing her 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 
certification to ORI at 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) Respondent agreed to exclude herself 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 two (2) years, beginning on May 6, 
2016.
    (5) As a condition of the Agreement, Respondent agreed to the 
retraction of the JBC 2010 publication.

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. 2016-13072 Filed 6-2-16; 8:45 am]
 BILLING CODE 4150-31-P