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)

Page Range		35785-35786
FR Document		2016-13072

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 Issue 107 (Friday, June 3, 2016)

[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

Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices 35785

Surprise, Arizona; Court of Federal 53. John Neukom; Normangee, Texas; 76. Scott Pudalov; Boulder, Colorado;
Claims No: 16–0459V Court of Federal Claims No: 16– Court of Federal Claims No: 16–
31. Linda K. Russell; Tampa, Florida; 0495V 0532V
Court of Federal Claims No: 16– 54. Heather Wright on behalf of B. W.; 77. Tracy Butler; Denver, Colorado;
0460V Washington, District of Columbia; Court of Federal Claims No: 16–
32. Steven Patton; Vienna, Virginia; Court of Federal Claims No: 16– 0534V
Court of Federal Claims No: 16– 0498V [FR Doc. 2016–13073 Filed 6–2–16; 8:45 am]
0461V 55. Julian Henley; Scottsbluff, Nebraska; BILLING CODE 4165–15–P
33. Scott Cipa; Vienna, Virginia; Court Court of Federal Claims No: 16–
of Federal Claims No: 16–0462V 0499V
34. Jessica Buckingham; New Castle, 56. Misty Pasco on behalf of M. P.; DEPARTMENT OF HEALTH AND
Delaware; Court of Federal Claims Phoenix, Arizona; Court of Federal HUMAN SERVICES
No: 16–0463V Claims No: 16–0500V
35. Mette Rose and Soren Rose Kjaer on 57. Janis Pool; Lawrence, Kansas; Court Office of the Secretary
behalf of F. R. K.; New York, New of Federal Claims No: 16–0503V
York; Court of Federal Claims No: 58. Jeffrey A. Bales; Greensboro, North Findings of Research Misconduct
16–0465V Carolina; Court of Federal Claims
36. Mette Rose and Soren Rose Kjaer on No: 16–0505V AGENCY: Office of the Secretary, HHS.
behalf of M. R. K.; New York, New 59. Terry Bartee; Antioch, California; ACTION: Notice.
York; Court of Federal Claims No: Court of Federal Claims No: 16–
16–0466V 0506V SUMMARY: Notice is hereby given that
37. Victoria Pusateri; Southgate, 60. Linda Barton; Lancaster, the Office of Research Integrity (ORI)
Michigan; Court of Federal Claims Pennsylvania; Court of Federal has taken final action in the following
No: 16–0467V Claims No: 16–0508V case:
38. Nathaniel Paul; Fairfax, Virginia; 61. Richard George Laux; Farmington Karen M. D’Souza, Ph.D., University
Court of Federal Claims No: 16– Hills, Michigan; Court of Federal of Chicago: Based on the report of an
0468V Claims No: 16–0509V investigation conducted by the
39. Rebecca S. Melgares; Milwaukee, 62. Judith A. Pannick; Flint, Michigan; University of Chicago (UC) and
Wisconsin; Court of Federal Claims Court of Federal Claims No: 16– additional analysis conducted by ORI in
No: 16–0470V 0510V its oversight review, ORI found that Dr.
40. Arthur L. Trollinger; Graham, North 63. Laura Kerrin; Philadelphia, Karen M. D’Souza, former Research
Carolina; Court of Federal Claims Pennsylvania; Court of Federal Professional Associate, Department of
No: 16–0473V Claims No: 16–0511V Surgery, UC, engaged in research
41. Tracy E. Carrozza; Princeton, New 64. Rev. Andrew Thomas Moody on misconduct in research supported by
Jersey; Court of Federal Claims No: behalf of E. G. M.; Houston, Texas; National Heart, Lung, and Blood
16–0474V Court of Federal Claims No: 16– Institute (NHLBI), National Institutes of
42. Allen O. Cabansag; Spring Valley, 0513V Health (NIH), grants K08 HL081472 and
California; Court of Federal Claims 65. James Ritchie; Ponte Vedra Beach, R01 HL107949.
No: 16–0475V Florida; Court of Federal Claims No: ORI found that falsified and/or
43. Luciana Desa; Washington, District 16–0514V fabricated data were included in the
of Columbia; Court of Federal 66. Thomas Smith; Weston, West following one (1) funded NIH grant, two
Claims No: 16–0476V Virginia; Court of Federal Claims (2) publications, two (2) posters, and
44. Deborah Tebault on behalf of J. T.; No: 16–0520V one (1) presentation:
Phoenix, Arizona; Court of Federal 67. Shahid Mahroof; Stony Brook, New • R01 HL107949–01
Claims No: 16–0478V York; Court of Federal Claims No: • J Biol Chem. 285(18):13748–60, 2010
45. Stephen Vasas; Ann Arbor, 16–0521V Apr 30 (hereafter referred to as ‘‘JBC
Michigan; Court of Federal Claims 68. Stephanie Smith; Allentown, 2010’’)
No: 16–0479V Pennsylvania; Court of Federal • J Biol Chem. 286(17):15507–16, 2011
46. Theresa Hibbs; Shepherdsville, Claims No: 16–0522V Apr 29 (hereafter referred to as ‘‘JBC
Kentucky; Court of Federal Claims 69. Monika Piatek on behalf of N. P.; 2011’’)
No: 16–0481V Chicago, Illinois; Court of Federal • Gordon Conference 2006 poster:
47. Stephanie Gilbert on behalf of P. L.; Claims No: 16–0524V ‘‘Regulation of Myocardial b-
Vienna, Virginia; Court of Federal 70. Patricia Rubio; Bedford, New Adrenergic Receptor Signaling By
Claims No: 16–0484V Hampshire; Court of Federal Claims Protein Kinase C’’ (hereafter referred
48. Sonya Tabor; Beverly Hills, No: 16–0525V to as ‘‘GC2006’’)
California; Court of Federal Claims 71. Frederick Morrison; Gulf Breeze, • Huggins 2010 poster: Gaq-mediated
No: 16–0485V Florida; Court of Federal Claims No: activation of GRK2 by mechanical
49. The Estate of Frank Lee Kapp, Jr., 16–0526V stretch in cardiac myocytes; the role
Deceased; Salisbury, North 72. Gary Schilling; Boston,
of protein kinase C’’ (hereafter
Carolina; Court of Federal Claims Massachusetts; Court of Federal
referred to as ‘‘HP2010’’)
No: 16–0487V Claims No: 16–0527V • Cardiac Research Day 2009
50. Leslie Lewis; Lexington, South 73. Tiffany Harris on behalf of A. H.;
presentation: ‘‘Regulation of G
mstockstill on DSK3G9T082PROD with NOTICES

Carolina; Court of Federal Claims Boston, Massachusetts; Court of
protein-coupled receptor signaling by
No: 16–0488V Federal Claims No: 16–0528V
51. Christine Benshoff; Orwigsburg, 74. Lianna Roberts; Boston, mechanical stretch in cardiac
Pennsylvania; Court of Federal Massachusetts; Court of Federal myocytes’’ (hereafter referred to as
Claims No: 16–0489V Claims No: 16–0529V ‘‘CR2009’’)
52. Robert Hearn; Jackson, Mississippi; 75. Jennifer Young; Canton, Michigan; ORI found that Respondent reused
Court of Federal Claims No: 16– Court of Federal Claims No: 16– and falsely relabeled and/or falsely
0493V 0530V spliced Western blot images, falsified

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35786 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices

the related densitometry measurements research, any institution employing her (5) As a condition of the Agreement,
based on the falsified Western blots, and shall ensure that a plan for supervision Respondent agreed to the retraction of
falsified and/or fabricated data for of her duties is submitted to ORI for the JBC 2010 publication.
experiments that were not performed or approval. The supervision plan must be FOR FURTHER INFORMATION CONTACT:
from unrelated experiments. designed to ensure the scientific Director, Office of Research Integrity,
Specifically, Respondent falsified integrity of Respondent’s PHS- 1101 Wootton Parkway, Suite 750,
and/or fabricated data in the following: supported research contribution and Rockville, MD 20852, (240) 453–8200.
• R01 HL107949–01 for: include the specific elements as
D Figure 1B for Western blots of a- outlined below. Respondent agreed that Kathryn M. Partin,
smooth muscle actin (a-SMA), she shall not participate in any PHS- Director, Office of Research Integrity.
Vimentin, Collagen I and supported research until such a [FR Doc. 2016–13072 Filed 6–2–16; 8:45 am]
Glyceraldehyde 3-Phosphate supervision plan is submitted to and BILLING CODE 4150–31–P
Dehydrogenase (GAPDH) expression approved by ORI. Respondent agreed to
in human cardiac fibroblasts isolated maintain responsibility for compliance
from failing left ventricles (HF) and with the agreed upon supervision plan. DEPARTMENT OF HEALTH AND
non-failing heart controls (CF) (2) The requirements for Respondent’s HUMAN SERVICES
D Figure 2A for Western blots of G supervision plan are as follows:
protein-coupled receptor kinase-2 i. A committee of senior faculty Indian Health Service
(GRK2) and GAPDH expression in HF members and officials at the institution
who are familiar with Respondent’s Notice of Tribal Consultation and
and CF, and the related densitometric Urban Confer Sessions on the State of
field of research, but not including
analysis the Great Plains Area Indian Health
Respondent’s supervisor or
• JBC 2011 for: Service
collaborators, will provide oversight and
D Figure 1A for a Western blot of
guidance for two (2) years beginning on
Vimentin expression in HF and CF, AGENCY: Indian Health Service (IHS),
May 6, 2016. The committee will review
and the related densitometric analysis Department of Health and Human
PHS-supported primary data from
D Figures 1D and 2D for Western blots Services.
Respondent and submit a report to ORI
of GAPDH expression in HF and CF, ACTION: Notice of Tribal consultation
at six (6) month intervals, setting forth
and the related densitometric analyses and urban confer sessions on the state
the committee meeting dates,
• JBC 2010 for: of the Great Plains Area IHS.
Respondent’s compliance with
D Figure 7A for Western blots of
appropriate research standards, and
phosphorylated Rhodopsin (Rho) and SUMMARY: Notice is hereby given that
confirming the integrity of Respondent’s
GRK2 expression in non-transgenic the Indian Health Service will conduct
PHS-supported research.
(NTG) (lanes 1–4) and Protein Kinase ii. The committee will conduct an a 90 day tribal consultation and urban
Ca cardiac-specific activation advance review of any PHS grant confer regarding the State of the Great
(PKCaAC) transgenic (lanes 5–6) application (including supplements, Plains Area IHS. The IHS will conduct
mice, and Figure 7B for the related resubmissions, etc.), manuscripts two telephone tribal consultation and
densitometric analysis reporting PHS-funded research urban confer sessions on June 22, 2016
• GC2006, Figure 7, HP2010, Figure 5, submitted for publication, and abstracts. and August 10, 2016. The IHS will also
and CR2009, Slide 15 for: The review will include a discussion conduct two on-site tribal consultation
D Western blots of phosphorylated Rho with Respondent of the primary data and urban confer sessions on July 13,
and GRK2 expression in NTG and represented in those documents and 2016 in Aberdeen, South Dakota and on
PKCaAC transgenic mice, and the will include a certification that the data August 30, 2016 in Rapid City, South
related densitometric analysis presented in the proposed application/ Dakota.
• HP2010 for: publication is supported by the research
D Figure 5 for a Western blot of GRK2 DATES: The IHS will conduct two
record. telephone Tribal consultation and urban
expression in NTG and PKCaAC (3) Respondent agreed that for two (2)
transgenic mice, and the related confer sessions on June 22, 2016 and
years beginning on May 6, 2016, any
densitometric analysis August 10, 2016. The IHS will also
institution employing her shall submit,
Dr. D’Souza has entered into a conduct two on-site Tribal consultation
in conjunction with each application for
Voluntary Settlement Agreement with and urban confer sessions on July 13,
PHS funds, or report, manuscript, or
ORI, in which she voluntarily agreed to 2016 in Aberdeen, South Dakota, and on
abstract involving PHS-supported
the administrative actions set forth August 30, 2016 in Rapid City, SD.
research in which Respondent is
below: involved, a certification to ORI at that The on-site meetings in Aberdeen and
(1) Respondent agreed that for two (2) the data provided by Respondent are Rapid City, South Dakota will be
years beginning on May 6, 2016, any based on actual experiments or are conducted at the addresses noted below.
institution employing her shall submit otherwise legitimately derived and that Written comments must be received on
in conjunction with each application for the data, procedures, and methodology or before September 1, 2016 at the
U.S. Public Health Service (PHS) funds, are accurately reported in the address below.
or report, manuscript, or abstract application, report, manuscript, or Conference Call Information: 1–800–
involving PHS-supported research in abstract. 369–1747; Pass Code: 1381519.
which Respondent is involved, a (4) Respondent agreed to exclude ADDRESSES: The meetings will be held at
mstockstill on DSK3G9T082PROD with NOTICES

supervision plan to ORI. Respondent herself voluntarily from serving in any The Dakota Event Center located at 720
agreed that prior to the submission of an advisory capacity to PHS including, but Lamont Street, Aberdeen, South Dakota;
application for PHS support for a not limited to, service on any PHS and at the Rushmore Plaza Holiday Inn
research project on which the advisory committee, board, and/or peer Convention Center located at 505 N.
Respondent’s participation is proposed review committee, or as a consultant for Fifth Street, Rapid City, SD 57701,
and prior to Respondent’s participation a period of two (2) years, beginning on during the 13th Annual Direct Service
in any capacity on PHS-supported May 6, 2016. Tribes National Meeting.

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Document Created: 2018-02-08 07:30:05
Document Modified: 2018-02-08 07:30:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation		81 FR 35785

81 FR 35785 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary