[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Page 62875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26379]



[[Page 62875]]

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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: Findings of research misconduct have been made on the part of 
Rajendra Kadam, former Ph.D. student in pharmaceutical sciences, 
University of Colorado, Denver (UCD) (Respondent). Mr. Kadam engaged in 
research misconduct in research supported by National Eye Institute 
(NEI), National Institutes of Health (NIH), grants R01 EY018940, R01 
EY017533, R24 EY017045, and RC1 EY020361. The administrative actions, 
including debarment for a period of three (3) years, were implemented 
beginning on November 13, 2018, and are detailed below.

FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Interim 
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852, (240) 453-8200.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of 
Research Integrity (ORI) has taken final action in the following case:
    Rajendra Kadam, University of Colorado, Denver: Based on an 
investigation conducted by UCD, the Respondent's admission, and 
analysis conducted by ORI in its oversight review, ORI found that Mr. 
Rajendra Kadam, former Ph.D. student in pharmaceutical sciences, UCD, 
engaged in research misconduct in research supported by NEI, NIH, 
grants R01 EY018940, R01 EY017533, R24 EY017045, and RC1 EY020361.
    ORI found that Respondent engaged in research misconduct by 
knowingly and intentionally falsifying and/or fabricating data by 
manipulating LC-MS/MS peak area data to reduce variability and/or alter 
statistical significance for twenty-six (26) figures and five (5) 
tables in his Ph.D. thesis and in the following nine (9) published 
papers:
     Drug Metab. Dispos. 41:466-474, 2013 (hereafter referred 
to as ``Drug Metab. Dispos. 2013''). Retracted in: Drug Metab. Dispos. 
43(2):234, 2015 Feb.
     Mol. Pharm. 10:2350-2361, 2013 (hereafter referred to as 
``Mol. Pharm. 2013''). Retracted in: Mol. Pharm. 12(7):2559, 2015 July 
6.
     Invest. Ophthalmol. Vis. Sci. 52(8):5387-99, 2011 
(hereafter referred to as ``IOVS 2011''). Retracted in: Invest. 
Ophthalmol. Vis. Sci. 56(3):1678, 2015 Mar 9.
     J. Control. Release 172(3):1151-60, 2013 (hereafter 
referred to as ``J. Control. Release 2013''). Retracted in: J. Control. 
Release 237:186, 2016 Sep 10.
     Int. J. Pharm. 434: 140-147, 2012 (hereafter referred to 
as ``Int. J. Pharm. 2012''). Retracted (no date provided by the journal 
for the retraction notice).
     Mol. Pharm. 9:605-614, 2012 (hereafter referred to as 
``Mol. Pharm. 2012''). Retracted in: Mol. Pharm. 12(7): 2558, 2015 July 
6.
     J. Pharmacol. Exp. Ther. 332:1107-1120, 2010 (hereafter 
referred to as ``J. Pharmacol. Exp. Ther. 2010''). Retracted in: J. 
Pharmacol. Exp. Ther. 352(2):326, 2015 Feb.
     Mol. Vis. 19:1198-1210, 2013 (hereafter referred to as 
``Mol. Vis. 2013'').
     Curr. Pharm. Biotechnol. 12(2):285-292, 2011 (hereafter 
referred to as ``Curr. Pharm. Biotechnol. 2011''). Erratum in: Curr. 
Pharm. Biotechnol. 17(9):846, 2016 Jun 6.\1\
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    \1\ While this publication does not cite U.S. Public Health 
Service (PHS) funding in its acknowledgements, Mr. Kadam was funded 
through his advisor's NIH funding while performing these 
experiments.
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    Specifically, Respondent falsified data included in:
     Figures 3.10 and 3.11 of respondent's thesis (also 
included as Figures 10 and 11 in Drug Metab. Disposal. 2013).
     Figures 5.2-5.7 of respondent's thesis.
     Figures 4.4-4.7 of respondent's thesis (also included as 
Figures 4-7 of Mol. Pharm. 2013).
     Figures 7.4, 7.5, and 7.7 of respondent's thesis (also 
included as Figures 1-5, 7, and 8 and summarized in Tables 2 and 3 of 
IOVS 2011).
     Figure 6 of J. Control. Release 2013.
     Figures 6-7 of Mol. Vis. 2013.
     Figure 3 in Int. J. Pharm. 2012.
     Figures 3 and 5-7 in Mol. Pharm. 2012.
     Figure 6C in Curr. Pharm. Biotechnol. 2011.
     Tables 3-5 and Figures 1-5 in J. Pharmacol. Exp. Ther. 
2010.
    Mr. Kadam entered into a Voluntary Exclusion Agreement (Agreement) 
and voluntarily agreed:
    (1) To exclude himself from any contracting or subcontracting with 
any agency of the United States Government and from eligibility for or 
involvement in nonprocurement programs of the United States Government 
referred to as ``covered transactions'' pursuant to HHS' Implementation 
(2 CFR part 376) of OMB Guidelines to Agencies on Governmentwide 
Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment 
Regulations'') for a period of three (3) years beginning on November 
13, 2018;
    (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 for a period of 
three (3) years beginning on November 13, 2018; and
    (3) as a condition of the Agreement, to request that the following 
paper be retracted:
     Mol. Vis. 19:1198-1210, 2013.

Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-26379 Filed 12-4-18; 8:45 am]
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