Findings of Research Misconduct, 70187-70188 [2014-27813]
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70187
Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
burden per
response
(in hours)
Total
burden
hours
Form name
Charged at rate of Healthcare Providers and Suppliers.
Charged at rate of Beneficiaries .......
Form A .............................................
240
1
11/60
44
Form A .............................................
160
1
11/60
29
Total ...........................................
...........................................................
400
1
11/60
73
OS specifically requests comments on
(1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2014–27835 Filed 11–24–14; 8:45 am]
BILLING CODE 4150–46–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Dr. Igor Dzhura, Vanderbilt
University: Based on an inquiry
conducted and admission obtained by
Vanderbilt University (VU) and
additional analysis conducted by ORI in
its oversight review, ORI found that Dr.
Igor Dzhura, former Senior Research
Associate, Department of Biomedical
Engineering, VU, engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Heart, Lung, and
Blood Institute (NHLBI), National
Institutes of Health (NIH), grants R01
HL070250, R01 HL062494, P01
HL046681, and K08 HL03727, National
Institute of Arthritis and
Musculoskeletal and Skin Diseases
(NIAMS), NIH, grant R01 AR044864,
National Institute of Mental Health
(NIMH), NIH, grant R01 MH063232,
National Institute of Allergy and
Infectious Diseases (NIAID), NIH, grant
U01 AI06223, and National Cancer
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SUMMARY:
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Number of
respondents
Number
responses per
respondent
Type of
respondent
Institute (NCI), NIH, grant U54
CA113007.
ORI found that Respondent engaged
in research misconduct by providing
falsified and/or fabricated data to his
supervisor and colleagues. Specifically,
Respondent:
• Submitted falsified cytosolic calcium
buffering experiments to his research
supervisor by misrepresenting
apparent action potential traces; these
actually were fluorescent calcium
transients merged with sodium
calcium exchange currents from a
different experiment; Respondent
admitted to falsely claiming ten
replicates for each trace when only
testing three to five cells
• falsified sodium calcium exchange
(NCX) activity in Very Long Chain
Acid Dehydrogenase Deficient
(VLCAD) mice versus wild type mice
in a PowerPoint presentation by
falsely labeling and manipulating
NCX data from a different experiment
testing an unrelated compound; the
effect was to falsely claim a difference
in NCX activity between the two
mouse phenotypes
• provided a falsified Figure 6C in a
manuscript submitted to Nature Cell
Biology, while claiming that the data
were based on Respondent’s memory
of his data that had purportedly been
collected and lost; Respondent
claimed to have tested one hundred
fifty (150) cells for their action
potential characteristics when the
experimental record only accounted
for approximately twenty (20).
ORI found that Respondent engaged
in research misconduct by falsifying
and/or fabricating the research record of
patch-clamp data. Specifically,
Respondent:
• Created a hierarchy of computer
folders containing duplicated and
renamed files; the falsified groups of
files included eighty-two (82) groups
of duplicated files with each group
containing two to twenty-one (2–21)
duplicates, which made it appear that
experiments were conducted when
they were not
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Fmt 4703
Sfmt 4703
• used the falsified and/or fabricated
data files in Figure 6 of a paper
published in the American Journal of
Physiology-Heart and Circulatory
Physiology (292(5):H2202–H2211,
2007), to represent Ca+ currents in
cardiac myocytes from CLCAD-/mice; specifically, Respondent
claimed that Figure 6 represented
results from seven (7) mice when the
data files were three (3) sets of
duplicated and renamed files plus one
additional data file. All of the data
files were part of larger groups of
identical duplicated and renamed
data files on the Respondent’s hard
drive.
ORI found that Respondent engaged
in research misconduct by submitting
and publishing multiple falsified and/or
fabricated action potential traces and
summary data in at least sixty-nine (69)
images in twelve (12) different figures
across seven (7) publications and three
(3) grant applications by duplication
and relabeling of traces; resizing,
modifying, and splicing different traces;
and modifying and/or duplicating bar
graphs.
The evidence established that
Respondent engaged in research
misconduct, as defined by the PHS
regulation, in that he significantly
departed from accepted research
practices by engaging in the intentional
and knowing fabrication and
falsification of data files.
Dr. Dzhura has entered into a
Voluntary Exclusion Agreement
(Agreement) and has voluntarily agreed
for a period of three (3) years, beginning
on October 29, 2014:
(1) To exclude himself from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility or involvement in
nonprocurement programs of the United
States Government referred to as
‘‘covered transactions’’ pursuant to
HHS’ Implementation (2 CFR part 376 et
seq) of OMB Guidelines to Agencies on
Governmentwide Debarment and
Suspension, 2 CFR part 180 (collectively
the ‘‘Debarment Regulations’’);
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25NON1
70188
Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices
(2) to exclude himself 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;
and
(3) to retract or correct the following
publications:
• Nature Cell Biology 2:173–177, 2000
• J. Physiol. 535(3):679–687, 2001
• Circulation 106:1288–1293, 2002
• J. Physiol. 545(2):399–406, 2002
• J. Physiol. 550(3):731–738, 2003
• FASEB J. 19:1573–1585, 2005
• Molecular Cell 23:641–650, 2006
FOR FURTHER INFORMATION CONTACT:
Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453–
8200.
Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2014–27813 Filed 11–24–14; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
changes to the currently approved
information collection project: ‘‘Medical
Expenditure Panel Survey (AMPS)
Household Component’’ In accordance
with the Paperwork Reduction Act, 44
U.S.C. 3501–3521, AHRQ invites the
public to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on August 29th, 2014 and
allowed 60 days for public comment.
One comment was received. The
purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by December 26, 2014.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
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SUMMARY:
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Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Medical Expenditure Panel Survey
(MEPS) Household Component
For over thirty years, results from the
MEPS and its predecessor surveys (the
1977 National Medical Care
Expenditure Survey, the 1980 National
Medical Care Utilization and
Expenditure Survey and the 1987
National Medical Expenditure Survey)
have been used by OMB, DHHS,
Congress and a wide number of health
services researchers to analyze health
care use, expenses and health policy.
Major changes continue to take place
in the health care system. The MEPS is
needed to provide information about the
current state of the health care system
as well as to track changes over time.
The MEPS permits annual estimates of
use of health care and expenditures and
sources of payment for that health care.
It also permits tracking individual
change in employment, income, health
insurance and health status over two
years. The use of the National Health
Interview Survey (NHIS) as a sampling
frame expands the MEPS analytic
capacity by providing another data
point for comparisons over time.
Households selected for participation
in the MEPS–HC are interviewed in
person five times. These rounds of
interviewing are spaced about 5 months
apart. The interview will take place
with a family respondent who will
report for him/herself and for other
family members.
The MEPS–HC has the following goal:
• To provide nationally
representative estimates for the U.S.
civilian noninstitutionalized population
for health care use, expenditures,
sources of payment and health
insurance coverage.
This study is being conducted by
AHRQ through its contractor, Westat,
pursuant to AHRQ’s statutory authority
to conduct and support research on
health care and on systems for the
delivery of such care, including
activities with respect to the cost and
use of health care services and with
respect to health statistics and surveys.
42 U.S.C. 299a(a)(3) and (8); 42 U.S.C.
299b–2.
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Method of Collection
To achieve the goals of the MEPS–HC
the following data collections are
implemented:
1. Household Component Core
Instrument. The core instrument
collects data about persons in sample
households. Topical areas asked in each
round of interviewing include condition
enumeration, health status, health care
utilization including prescribed
medicines, expense and payment,
employment, and health insurance.
Other topical areas that are asked only
once a year include access to care,
income, assets, satisfaction with health
plans and providers, children’s health,
and adult preventive care. While many
of the questions are asked about the
entire reporting unit, which is typically
a family, only one person normally
provides this information.
2. Adult Self Administered
Questionnaire. A brief self-administered
questionnaire (SAQ) will be used to
collect self-reported (rather than
through household proxy) information
on health status, health opinions and
satisfaction with health care for adults
18 and older. The items on satisfaction
with health care are a subset from the
Consumer Assessment of Healthcare
Providers and Systems. The health
status items are from the Short Form 12
Version 2, which has been widely used
as a measure of self-reported health
status in the United States, the Kessler
Index of non-specific psychological
distress, and the Patient Health
Questionnaire.
3. Diabetes Care SAQ. A brief selfadministered, paper-and-pencil
questionnaire on the quality of diabetes
care is administered once a year, during
rounds 3 and 5, to persons identified as
having diabetes. Included are questions
about the number of times the
respondent reported having a
hemoglobin A1c blood test, whether the
respondent reported having his or her
feet checked for sores or irritations,
whether the respondent reported having
an eye exam in which his or her pupils
were dilated, the last time the
respondent had his or her blood
cholesterol checked and whether the
diabetes has caused kidney or eye
problems. Respondents are also asked if
their diabetes is being treated with diet,
oral medications or insulin.
4. Permission forms for the MEPS–
MPC Provider and Pharmacy Survey. As
in previous panels of the MEPS, we will
ask respondents for permission to obtain
supplemental information from their
medical providers (hospitals,
physicians, home health agencies and
institutions) and pharmacies.
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Agencies
[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70187-70188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27813]
-----------------------------------------------------------------------
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:
Dr. Igor Dzhura, Vanderbilt University: Based on an inquiry
conducted and admission obtained by Vanderbilt University (VU) and
additional analysis conducted by ORI in its oversight review, ORI found
that Dr. Igor Dzhura, former Senior Research Associate, Department of
Biomedical Engineering, VU, engaged in research misconduct in research
supported by U.S. Public Health Service (PHS) funds, specifically
National Heart, Lung, and Blood Institute (NHLBI), National Institutes
of Health (NIH), grants R01 HL070250, R01 HL062494, P01 HL046681, and
K08 HL03727, National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS), NIH, grant R01 AR044864, National Institute of
Mental Health (NIMH), NIH, grant R01 MH063232, National Institute of
Allergy and Infectious Diseases (NIAID), NIH, grant U01 AI06223, and
National Cancer Institute (NCI), NIH, grant U54 CA113007.
ORI found that Respondent engaged in research misconduct by
providing falsified and/or fabricated data to his supervisor and
colleagues. Specifically, Respondent:
Submitted falsified cytosolic calcium buffering experiments to
his research supervisor by misrepresenting apparent action potential
traces; these actually were fluorescent calcium transients merged with
sodium calcium exchange currents from a different experiment;
Respondent admitted to falsely claiming ten replicates for each trace
when only testing three to five cells
falsified sodium calcium exchange (NCX) activity in Very Long
Chain Acid Dehydrogenase Deficient (VLCAD) mice versus wild type mice
in a PowerPoint presentation by falsely labeling and manipulating NCX
data from a different experiment testing an unrelated compound; the
effect was to falsely claim a difference in NCX activity between the
two mouse phenotypes
provided a falsified Figure 6C in a manuscript submitted to
Nature Cell Biology, while claiming that the data were based on
Respondent's memory of his data that had purportedly been collected and
lost; Respondent claimed to have tested one hundred fifty (150) cells
for their action potential characteristics when the experimental record
only accounted for approximately twenty (20).
ORI found that Respondent engaged in research misconduct by
falsifying and/or fabricating the research record of patch-clamp data.
Specifically, Respondent:
Created a hierarchy of computer folders containing duplicated
and renamed files; the falsified groups of files included eighty-two
(82) groups of duplicated files with each group containing two to
twenty-one (2-21) duplicates, which made it appear that experiments
were conducted when they were not
used the falsified and/or fabricated data files in Figure 6 of
a paper published in the American Journal of Physiology-Heart and
Circulatory Physiology (292(5):H2202-H2211, 2007), to represent Ca+
currents in cardiac myocytes from CLCAD-/- mice; specifically,
Respondent claimed that Figure 6 represented results from seven (7)
mice when the data files were three (3) sets of duplicated and renamed
files plus one additional data file. All of the data files were part of
larger groups of identical duplicated and renamed data files on the
Respondent's hard drive.
ORI found that Respondent engaged in research misconduct by
submitting and publishing multiple falsified and/or fabricated action
potential traces and summary data in at least sixty-nine (69) images in
twelve (12) different figures across seven (7) publications and three
(3) grant applications by duplication and relabeling of traces;
resizing, modifying, and splicing different traces; and modifying and/
or duplicating bar graphs.
The evidence established that Respondent engaged in research
misconduct, as defined by the PHS regulation, in that he significantly
departed from accepted research practices by engaging in the
intentional and knowing fabrication and falsification of data files.
Dr. Dzhura has entered into a Voluntary Exclusion Agreement
(Agreement) and has voluntarily agreed for a period of three (3) years,
beginning on October 29, 2014:
(1) To exclude himself from any contracting or subcontracting with
any agency of the United States Government and from eligibility or
involvement in nonprocurement programs of the United States Government
referred to as ``covered transactions'' pursuant to HHS' Implementation
(2 CFR part 376 et seq) of OMB Guidelines to Agencies on Governmentwide
Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment
Regulations'');
[[Page 70188]]
(2) to exclude himself 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; and
(3) to retract or correct the following publications:
Nature Cell Biology 2:173-177, 2000
J. Physiol. 535(3):679-687, 2001
Circulation 106:1288-1293, 2002
J. Physiol. 545(2):399-406, 2002
J. Physiol. 550(3):731-738, 2003
FASEB J. 19:1573-1585, 2005
Molecular Cell 23:641-650, 2006
FOR FURTHER INFORMATION CONTACT: Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8200.
Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2014-27813 Filed 11-24-14; 8:45 am]
BILLING CODE P