Findings of Research Misconduct, 70187-70188 [2014-27813]

Download as PDF 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 wreier-aviles on DSK4TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:41 Nov 24, 2014 Jkt 235001 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 PO 00000 Frm 00032 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’’); E:\FR\FM\25NON1.SGM 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). wreier-aviles on DSK4TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:41 Nov 24, 2014 Jkt 235001 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. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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. E:\FR\FM\25NON1.SGM 25NON1

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]


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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:
    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