[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Pages 26065-26066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12047]


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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 
Shiladitya Sen, former graduate student, Department of Chemistry and 
Biochemistry, The Ohio State University (OSU). Mr. Sen engaged in 
research misconduct in research supported by National Institute of 
General Medical Sciences (NIGMS), National Institutes of Health (NIH), 
grant R01 GM083114. The administrative actions, including debarment for 
a period of three (3) years, were implemented beginning on May 16, 
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.

[[Page 26066]]


SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of 
Research Integrity (ORI) has taken final action in the following case:
    Shiladitya Sen, The Ohio State University: Based on the report of 
an investigation conducted by OSU and analysis conducted by ORI in its 
oversight review, ORI found that Mr. Shiladitya Sen, former graduate 
student, OSU, engaged in research misconduct in research supported by 
NIGMS, NIH, grant R01 GM083114.
    ORI found that Respondent engaged in research misconduct by 
knowingly and intentionally falsifying and/or fabricating data reported 
in the following published paper, his Ph.D. thesis, a poster 
presentation, and his mentor's grant applications submitted to NIGMS, 
NIH:

 PNAS 110(11):4261-4266, 2013 (hereafter referred to as ``PNAS 
2013''); retracted in: PNAS 114(37):E7855, 2017 Sep
 Sen, S. ``Engineering Proteins for Enhanced Stability using 
High-Throughput and Combinatorial Methods.'' OSU Doctoral Dissertation, 
2013 (hereafter referred to as ``thesis'')
 poster presented at the Annual Symposium of the Protein 
Society in 2012 (hereafter referred to as ``Poster 2012'')
 R01 GM083114 and R01 GM083114-A1

    ORI found that Respondent knowingly and intentionally falsified 
and/or fabricated gene sequencing and high throughput thermal scanning 
(HTTS) data for sequence-stability relationship of Rop protein variants 
in nineteen (19) figures, ten (10) tables, and related text included in 
a poster presentation, his Ph.D. thesis, and two (2) NIH grant 
applications.
    Specifically, Respondent knowingly and intentionally falsified and/
or fabricated:

 Unique sequences and stability data for 1017 active Rop 
variants in Table 3.1 and provided additional analyses purportedly from 
those active Rop variants in Table 3.2 and Figures 3.3, 3.4, 3.5, 3.6, 
3.7, 3.8, and 3.9 in his thesis and in Figures 6, 7, 17, and 20 in two 
(2) grant applications
 unique sequences and stability data for active Rop loop 
variants from four separate mutant libraries, X4, 
LX4, X4-I, LX4-I in Tables 5.2, 5.3, 
5.4, and 5.5, respectively, and presented additional analyses 
purportedly from those active Rop loop variants in Figures 5.3, 5.4, 
5.5, 5.6, and 5.9 and Table 5.1 in his thesis and in Figure 6 in two 
(2) grant applications
 figures entitled ``analysis of more than 1000 active (folded) 
core variants,'' ``Loop Library: How does loop affect stability?'' and 
``Detailed characterization of loop variants'' in Poster 2012
 list of oligonucleotides included in Tables 9.2, 9.3, and 9.4 
in his thesis

    ORI also found that Respondent knowingly and intentionally 
falsified and/or fabricated HTTS data for thermodynamic effects of 
somatic mutation in antibodies 93F3 and OKT3 in ten (10) figures, two 
(2) tables, and related text included in PNAS 2013 and his thesis.
    Specifically, Respondent knowingly and intentionally falsified and/
or fabricated HTTS data:

 In Figures 6.2A, 6.2C, 6.3, and 6.6 and Tables 6.2 and 6.3 in 
his thesis
 also included as Figures 2A, 2C, S2, and S5 and Tables S3 and 
S4 in PNAS 2013
    Mr. Sen entered into a Voluntary Exclusion Agreement and 
voluntarily agreed for a period of three (3) years, beginning on May 
16, 2018:
    (1) To exclude himself voluntarily 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'');
    (2) to exclude himself 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.

Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-12047 Filed 6-4-18; 8:45 am]
 BILLING CODE 4150-31-P