80_FR_76940 80 FR 76703 - Findings of Research Misconduct

80 FR 76703 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 237 (December 10, 2015)

Page Range76703-76704
FR Document2015-31057

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Girija Dasmahapatra, Ph.D., Virginia Commonwealth University: Based on the report of an inquiry conducted by Virginia Commonwealth University (VCU), the willingness of the Respondent to settle this matter, and analysis conducted by ORI in its oversight review, ORI found that Dr. Girija Dasmahapatra, former Instructor, Department of Internal Medicine, VCU, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA063753, R01 CA093738, and R01 CA100866. ORI found that false data were included in the following eleven (11) publications:

Federal Register, Volume 80 Issue 237 (Thursday, December 10, 2015)
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76703-76704]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31057]


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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.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Girija Dasmahapatra, Ph.D., Virginia Commonwealth University: Based 
on the report of an inquiry conducted by Virginia Commonwealth 
University (VCU), the willingness of the Respondent to settle this 
matter, and analysis conducted by ORI in its oversight review, ORI 
found that Dr. Girija Dasmahapatra, former Instructor, Department of 
Internal Medicine, VCU, engaged in research misconduct in research 
supported by National Cancer Institute (NCI), National Institutes of 
Health (NIH), grants R01 CA063753, R01 CA093738, and R01 CA100866.
    ORI found that false data were included in the following eleven 
(11) publications:

 Blood 107:232-40, 2006 Jan (hereafter referred to as ``Blood 
2006'')
 Blood 115:4478-87, 2010 Jun 3 (hereafter referred to as 
``Blood 2010'')
 British Journal of Haematology 161:43-56, 2013 Apr (hereafter 
referred to as ``BJH 2013'')
 Cancer Biology & Therapy 8:808-19, 2009 May (hereafter 
referred to as ``CBT 2009'')
 Clinical Cancer Research 13:4280-90, 2007 Jul (hereafter 
referred to as ``CCR 2007'')
 Leukemia 19:1579-89, 2005 Sep (hereafter referred to as ``Leuk 
2005'')
 Leukemia Research 30:1263-1272, 2006 (hereafter referred to as 
``LR 2006'')
 Molecular Cancer Therapeutics 10:1686-97, 2011 Sep (hereafter 
referred to as ``MCT 2011'')
 Molecular Cancer Therapeutics 11:1122-32, 2012 May (hereafter 
referred to as ``MCT 2012'')
 Molecular Cancer Therapeutics 13:2886-97, 2014 Dec (hereafter 
referred to as ``MCT 2014'')
 Molecular Pharmacology 69:288-98, 2006 Jan (hereafter referred 
to as ``MP 2006'')

    ORI found that Respondent falsified and/or fabricated data by 
reporting the results of Western blot experiments and mouse imaging 
experiments that examined interactions between multiple histone 
deacetylase and/or proteasome inhibitors in several cancer models. 
Specifically, Respondent duplicated, reused, and/or relabeled Western 
blot panels and mouse images and claimed they represented different 
controls and/or experimental results in:

 Blood 2006, Figures 2A and 2B (Tubulin), 2C (c-Jun & Tubulin), 
and 3E and 3F (Tubulin)
 Blood 2010, Figures 4A and 4C (JNK & Tubulin)
 BJH 2013, Figures 2A and 6B (Tubulin)
 CBT 2009, Figure 4B (Actin)
 CCR 2007, Figures 3B (PARP) and 6A (Tubulin)

[[Page 76704]]

 Leuk 2005, Figures 3B (PARP CF) and 4A, 4B, and 4C (Tubulin)
 LR 2006, Figure 3D (Actin--BaF/3-WT)
 MCT 2011, Figures 2B and 3D (Tubulin) and 6B (0 d--CFZ-2.0mg/
Kg & 12 d--CFZ + VOR)
 MCT 2012, Figures 3A (JNK & Tubulin, 3B (Tubulin--scram), 3D 
(Tubulin--pUSE-AKT cl.3), and 6B (CFZ + obato)
 MCT 2014, Figures 3A (JNK 1 & Tubulin), 3B (JNK & Tubulin), 
and 3C (Tubulin)
 MP 2006, Figures 1D and 1E (Caspase 3, CF Caspase 3, PARP & 
Tubulin), 2C (PARP), 3B, 4A, and 4B (Tubulin), 6A (Tubulin--U937-pSFFv 
12 hr treatment & U937-Bcl-2-[Delta]N 24 hr treatment), and 9A (Cox-IV)

    Dr. Dasmahapatra has entered into a Voluntary Exclusion Agreement 
(Agreement) and has voluntarily agreed:
    (1) To exclude himself for a period of three (3) years from the 
effective date of the Agreement 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'');
    (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 period of 
three (3) years, beginning on November 5, 2015; and
    (3) That the following publications will be retracted or corrected: 
Blood 2006, Blood 2010, BJH 2013, CBT 2009, CCR 2007, Leuk 2005, LR 
2006, MCT 2011, MCT 2012, MCT 2014, and MP 2006.

FOR FURTHER INFORMATION CONTACT: Acting Director, Division of 
Investigative Oversight, 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. 2015-31057 Filed 12-9-15; 8:45 am]
 BILLING CODE 4150-31-P



                                                                            Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices                                   76703

                                                  Viral Hepatitis: Action Plan for the                       b. Training and/or increasing capacity    report of an inquiry conducted by
                                                  Prevention, Care, & Treatment of Viral                  of health care providers to prevent,         Virginia Commonwealth University
                                                  Hepatitis 2014–2016, details more than                  diagnose, treat viral hepatitis;             (VCU), the willingness of the
                                                  150 actions to be undertaken between                       c. Developing strategies to promote       Respondent to settle this matter, and
                                                  2014 and 2016 by 20 federal agencies                    timely viral hepatitis diagnosis and         analysis conducted by ORI in its
                                                  and offices from across the U.S.                        linkage to care;                             oversight review, ORI found that Dr.
                                                  Departments of Health and Human                            d. Developing/implementing clinical       Girija Dasmahapatra, former Instructor,
                                                  Services (HHS), Housing and Urban                       decision support tools and/or improved       Department of Internal Medicine, VCU,
                                                  Development (HUD), Justice (DOJ), and                   protocols in clinical settings that          engaged in research misconduct in
                                                  Veterans Affairs (VA). While the Viral                  improve viral hepatitis health outcomes;     research supported by National Cancer
                                                  Hepatitis Action Plan describes efforts                    e. Implementing strategies to educate     Institute (NCI), National Institutes of
                                                  to be undertaken by federal                             women of child-bearing age and high          Health (NIH), grants R01 CA063753, R01
                                                  stakeholders, many of the successes our                 risk groups about mother-to-infant           CA093738, and R01 CA100866.
                                                  nation has seen in the fight against viral              transmission of hepatitis B;                   ORI found that false data were
                                                  hepatitis have resulted from non-federal                   f. Reaching people who inject drugs       included in the following eleven (11)
                                                  efforts including those of health                       with viral hepatitis information and         publications:
                                                                                                          services;
                                                  departments, academic researchers,
                                                                                                             g. Improving viral hepatitis infection    • Blood 107:232–40, 2006 Jan (hereafter
                                                  community-based organizations,                                                                         referred to as ‘‘Blood 2006’’)
                                                                                                          prevention awareness and initiatives in
                                                  professional organizations, education
                                                                                                          medical settings;                            • Blood 115:4478–87, 2010 Jun 3
                                                  and advocacy groups, private industry,                                                                 (hereafter referred to as ‘‘Blood 2010’’)
                                                                                                             h. Developing strategies to foster
                                                  and other stakeholders. The Viral
                                                                                                          stakeholder collaboration and                • British Journal of Haematology
                                                  Hepatitis Action Plan provides a                                                                       161:43–56, 2013 Apr (hereafter
                                                                                                          sustainable programs; and
                                                  framework around which all                                 i. Other (please specify).                  referred to as ‘‘BJH 2013’’)
                                                  stakeholders can engage to strengthen                      4. Please include relevant information    • Cancer Biology & Therapy 8:808–19,
                                                  the nation’s response to viral hepatitis                such as the dates of implementation;           2009 May (hereafter referred to as
                                                  and envisions active involvement of and                 names of collaborating organizational          ‘‘CBT 2009’’)
                                                  innovation by a broad mix of partners                   partners; related Action Plan goal(s);       • Clinical Cancer Research 13:4280–90,
                                                  from both public and private sectors.                   geographic area and populations served,        2007 Jul (hereafter referred to as ‘‘CCR
                                                     The updated Action Plan describes                    quantitative findings and outcomes such        2007’’)
                                                  four main goals to be achieved by 2020:                 as number of tests done, proportion of       • Leukemia 19:1579–89, 2005 Sep
                                                     • Increase in the proportion of                                                                     (hereafter referred to as ‘‘Leuk 2005’’)
                                                                                                          positives identified; and links to online
                                                  persons who are aware of their hepatitis                                                             • Leukemia Research 30:1263–1272,
                                                                                                          tools, resources, and publications.
                                                  B virus (HBV) infection, from 33% to                       Please limit responses to four pages,       2006 (hereafter referred to as ‘‘LR
                                                  66%.                                                    single-sided, double spaced, 10 point          2006’’)
                                                     • Increase in the proportion of                                                                   • Molecular Cancer Therapeutics
                                                                                                          font.
                                                  persons who are aware of their hepatitis                   Selected activities will be compiled        10:1686–97, 2011 Sep (hereafter
                                                  C virus (HCV) infection, from 45% to                    and made available to federal partners,        referred to as ‘‘MCT 2011’’)
                                                  66%.                                                    stakeholders, and the public in order to     • Molecular Cancer Therapeutics
                                                     • Reduce by 25% the number of new                                                                   11:1122–32, 2012 May (hereafter
                                                                                                          foster further expansion, innovation,
                                                  cases of HCV infection.                                                                                referred to as ‘‘MCT 2012’’)
                                                     • Eliminate mother-to-child                          and collaboration toward achieving the
                                                                                                          goals of the Viral Hepatitis Action Plan.    • Molecular Cancer Therapeutics
                                                  transmission of HBV.
                                                     This request for information seeks                   Reponses to this RFI will also be used         13:2886–97, 2014 Dec (hereafter
                                                  public comment on several key areas                     to inform future HHS strategic planning        referred to as ‘‘MCT 2014’’)
                                                                                                          and implementation.                          • Molecular Pharmacology 69:288–98,
                                                  with respect to non-federal efforts
                                                                                                                                                         2006 Jan (hereafter referred to as ‘‘MP
                                                  undertaken throughout calendar years                       Dated: December 7, 2015.
                                                                                                                                                         2006’’)
                                                  2014–2015 that are consistent with the                  Ronald O. Valdiserri,
                                                                                                                                                         ORI found that Respondent falsified
                                                  four main goals of the Viral Hepatitis                  Deputy Assistant Secretary for Health,
                                                                                                                                                       and/or fabricated data by reporting the
                                                  Action Plan. Comments are sought on                     Infectious Diseases, Office of the Assistant
                                                                                                                                                       results of Western blot experiments and
                                                  (but not limited to) the following:                     Secretary for Health.
                                                     1. Describe the type of organization or                                                           mouse imaging experiments that
                                                                                                          [FR Doc. 2015–31131 Filed 12–9–15; 8:45 am]
                                                  group with which you are affiliated                                                                  examined interactions between multiple
                                                                                                          BILLING CODE 4150–28–P
                                                  (e.g., advocacy, private industry, health                                                            histone deacetylase and/or proteasome
                                                  care, local, or state government, etc.).                                                             inhibitors in several cancer models.
                                                     2. What is the most significant need                 DEPARTMENT OF HEALTH AND                     Specifically, Respondent duplicated,
                                                  your community/clients experience                       HUMAN SERVICES                               reused, and/or relabeled Western blot
                                                  with respect to combating viral                                                                      panels and mouse images and claimed
                                                  hepatitis?                                              Office of the Secretary                      they represented different controls and/
                                                     3. What activities conducted in 2014                                                              or experimental results in:
                                                  and 2015 demonstrated the greatest                      Findings of Research Misconduct              • Blood 2006, Figures 2A and 2B
                                                  advances toward reaching the goals of                   AGENCY: Office of the Secretary, HHS.          (Tubulin), 2C (c-Jun & Tubulin), and
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  the Viral Hepatitis Action Plan?                        ACTION: Notice.
                                                                                                                                                         3E and 3F (Tubulin)
                                                  Responses are invited (but not limited                                                               • Blood 2010, Figures 4A and 4C (JNK
                                                  to) viral hepatitis activities in the                   SUMMARY: Notice is hereby given that           & Tubulin)
                                                  following areas:                                        the Office of Research Integrity (ORI)       • BJH 2013, Figures 2A and 6B
                                                     a. Raising awareness about viral                     has taken final action in the following        (Tubulin)
                                                  hepatitis among the general public,                     case:                                        • CBT 2009, Figure 4B (Actin)
                                                  specific targeted populations, and/or                      Girija Dasmahapatra, Ph.D., Virginia      • CCR 2007, Figures 3B (PARP) and 6A
                                                  community leaders;                                      Commonwealth University: Based on the          (Tubulin)


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                                                  76704                     Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices

                                                  • Leuk 2005, Figures 3B (PARP CF) and                   DEPARTMENT OF HOMELAND                                are to respond, including through the
                                                    4A, 4B, and 4C (Tubulin)                              SECURITY                                              use of appropriate automated,
                                                  • LR 2006, Figure 3D (Actin—BaF/3–                                                                            electronic, mechanical, or other
                                                                                                          United States Immigration and                         technological collection techniques or
                                                    WT)
                                                                                                          Customs Enforcement                                   other forms of information technology,
                                                  • MCT 2011, Figures 2B and 3D                                                                                 e.g., permitting electronic submission of
                                                    (Tubulin) and 6B (0 d—CFZ–2.0mg/                      Agency Information Collection                         responses.
                                                    Kg & 12 d—CFZ + VOR)                                  Activities: Comment Request;
                                                                                                          Extension of an Information Collection                Overview of This Information
                                                  • MCT 2012, Figures 3A (JNK &                                                                                 Collection
                                                    Tubulin, 3B (Tubulin—scram), 3D                       ACTION:  30-Day notice of information
                                                    (Tubulin—pUSE–AKT cl.3), and 6B                                                                               (1) Type of Information Collection:
                                                                                                          collection for review; G–79A;                         Extension of a currently approved
                                                    (CFZ + obato)                                         information relating to beneficiary of                information collection
                                                  • MCT 2014, Figures 3A (JNK 1 &                         Private Bill; OMB Control No. 1653–                     (2) Title of the Form/Collection:
                                                    Tubulin), 3B (JNK & Tubulin), and 3C                  0026.                                                 Information Relating to Beneficiary of
                                                    (Tubulin)                                                                                                   Private Bill.
                                                                                                             The Department of Homeland
                                                  • MP 2006, Figures 1D and 1E (Caspase                   Security, U.S. Immigration and Customs                  (3) Agency form number, if any, and
                                                    3, CF Caspase 3, PARP & Tubulin), 2C                  Enforcement (USICE), is submitting the                the applicable component of the
                                                    (PARP), 3B, 4A, and 4B (Tubulin), 6A                  following information collection request              Department of Homeland Security
                                                    (Tubulin—U937–pSFFv 12 hr                             for review and clearance in accordance                sponsoring the collection: G–79A; U.S.
                                                    treatment & U937-Bcl-2-DN 24 hr                       with the Paperwork Reduction Act of                   Immigration and Customs Enforcement
                                                    treatment), and 9A (Cox-IV)                           1995. The information collection is                     (4) Affected public who will be asked
                                                                                                          published in the Federal Register to                  or required to respond, as well as a brief
                                                     Dr. Dasmahapatra has entered into a                                                                        abstract: Primary: State, Local, or Tribal
                                                                                                          obtain comments from the public and
                                                  Voluntary Exclusion Agreement                                                                                 Government. Section 404(b) of the
                                                                                                          affected agencies. This information
                                                  (Agreement) and has voluntarily agreed:                 collection was previously published in                Immigration and Nationality Act (8
                                                     (1) To exclude himself for a period of               the Federal Register on September 21,                 U.S.C. 1101 note) provides for the
                                                  three (3) years from the effective date of              2015, Vol. 80 No. 23491 allowing for a                reimbursement of States and localities
                                                  the Agreement from any contracting or                   60 day comment period. No comments                    for assistance provided in meeting an
                                                  subcontracting with any agency of the                   were received on this information                     immigration emergency. This collection
                                                  United States Government and from                       collection. The purpose of this notice is             of information allows for State or local
                                                  eligibility or involvement in                           to allow an additional 30 days for public             governments to request reimbursement.
                                                  nonprocurement programs of the United                   comments.                                               (5) An estimate of the total number of
                                                                                                             Written comments and suggestions                   respondents and the amount of time
                                                  States Government referred to as
                                                                                                          regarding items contained in this notice              estimated for an average respondent to
                                                  ‘‘covered transactions’’ pursuant to
                                                                                                          and especially with regard to the                     respond: 10 responses at 30 minutes (.50
                                                  HHS’ Implementation (2 CFR part 376 et                                                                        hours) per response.
                                                  seq) of OMB Guidelines to Agencies on                   estimated public burden and associated
                                                                                                          response time should be directed to the                 (6) An estimate of the total public
                                                  Governmentwide Debarment and                                                                                  burden (in hours) associated with the
                                                  Suspension, 2 CFR part 180 (collectively                Office of Information and Regulatory
                                                                                                          Affairs, Office of Management and                     collection: 300 annual burden hours.
                                                  the ‘‘Debarment Regulations’’);
                                                                                                          Budget. Comments should be addressed                    Dated: December 7, 2015.
                                                     (2) To exclude himself from serving in               to the OMB Desk Officer for U.S.                      Scott Elmore,
                                                  any advisory capacity to PHS including,                 Immigration and Customs Enforcement,                  Program Manager, Forms Management Office,
                                                  but not limited to, service on any PHS                  Department of Homeland Security, and                  Office of the Chief Information Officer, U.S.
                                                  advisory committee, board, and/or peer                  sent via electronic mail to oira_                     Immigration and Customs Enforcement,
                                                  review committee, or as a consultant for                submission@omb.eop.gov or faxed to                    Department of Homeland Security.
                                                  period of three (3) years, beginning on                 (202) 395–5806.                                       [FR Doc. 2015–31108 Filed 12–9–15; 8:45 am]
                                                  November 5, 2015; and                                      Written comments and suggestions                   BILLING CODE 9111–28–P
                                                     (3) That the following publications                  from the public and affected agencies
                                                  will be retracted or corrected: Blood                   concerning the proposed collection of
                                                  2006, Blood 2010, BJH 2013, CBT 2009,                   information should address one or more                DEPARTMENT OF HOUSING AND
                                                  CCR 2007, Leuk 2005, LR 2006, MCT                       of the following four points:                         URBAN DEVELOPMENT
                                                                                                             (1) Evaluate whether the proposed
                                                  2011, MCT 2012, MCT 2014, and MP                                                                              [Docket No. FR–5835–N–28]
                                                                                                          collection of information is necessary
                                                  2006.
                                                                                                          for the proper performance of the
                                                                                                                                                                60-Day Notice of Proposed Information
                                                  FOR FURTHER INFORMATION CONTACT:                        functions of the agency, including
                                                                                                                                                                Collection: Multifamily Family Self-
                                                  Acting Director, Division of                            whether the information will have
                                                                                                                                                                Sufficiency (MF FSS) Program Escrow
                                                  Investigative Oversight, Office of                      practical utility;
                                                                                                                                                                Credit Data
                                                  Research Integrity, 1101 Wootton                           (2) Evaluate the accuracy of the
                                                  Parkway, Suite 750, Rockville, MD                       agencies estimate of the burden of the                AGENCY:  Office of the Assistant
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  20852, (240) 453–8200.                                  proposed collection of information,                   Secretary for Housing—Federal Housing
                                                                                                          including the validity of the                         Commissioner, HUD.
                                                  Donald Wright,                                          methodology and assumptions used;                     ACTION: Notice.
                                                  Acting Director, Office of Research Integrity.             (3) Enhance the quality, utility, and
                                                  [FR Doc. 2015–31057 Filed 12–9–15; 8:45 am]             clarity of the information to be                      SUMMARY:   HUD is seeking approval from
                                                  BILLING CODE 4150–31–P
                                                                                                          collected; and                                        the Office of Management and Budget
                                                                                                             (4) Minimize the burden of the                     (OMB) for the information collection
                                                                                                          collection of information on those who                described below. In accordance with the


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Document Created: 2015-12-14 13:29:25
Document Modified: 2015-12-14 13:29:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactActing Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation80 FR 76703 

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