81 FR 34357 - Findings of Research Misconduct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 81, Issue 104 (May 31, 2016)
Office of the Secretary
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34357-34358 | |
| FR Document | 2016-12800 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Notices] [Pages 34357-34358] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12800] ----------------------------------------------------------------------- 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: Ricky Malhotra, Ph.D., University of Michigan and University of Chicago: Based on the Respondent's admission to committing research misconduct at the University of Michigan (UM) and subsequently at the University of Chicago (UC), the reports of separate investigations conducted by UM and UC, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Ricky Malhotra, former Research Assistant Professor, Department of Internal Medicine, UM, from 2005- 2006, and Research Assistant Professor, Department of Surgery, UC, from 2007-2011, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants K08 HL081472 and R01 HL107949. ORI found that falsified and/or fabricated data were included in the following three (3) NIH grant applications, one (1) NIH grant progress report, one (1) publication, seven (7) presentations, and one (1) image file:R03 AG029508-01 R21 AG030361-01 R01 HL102405-01 K08 HL081472-05 Progress Report J Biol Chem. 285(18):13748-60, 2010 Apr 30 (hereafter referred to as ``JBC 2010'') Presentation: Autophagy Pathway.ppt, MKK4 expression after UV.ppt, Oct PPt.ppt, RicDec.ppt, Ricky Presentation 06.ppt, Ricky STC.ppt, and RM.ppt Image file: Final LC 3.jpg ORI found that Respondent reused and falsely relabeled Western blot gel images, falsified the related densitometry measurements based on the falsified Western blots, and falsified and/or fabricated data for experiments that were not performed. Respondent continued this falsification at UC, after the UM research misconduct investigation was completed. Specifically: While at UM, Respondent falsified and/or fabricated images in R03 AG029508-01 and three (3) presentations, where: [ssquf] R03 AG029508-01, Figure 2, represented Western blots for phosphorylated p53 (Ser15) and [beta]-actin expression in normal and Snell dwarf mice fibroblasts (mN/SF) treated with the DNA alkylating agent methyl methanesulfonate (MMS), when the same images were duplicated to represent different proteins and treatments in the presentations Autophagy Pathway.ppt and RM.ppt. [ssquf] R03 AG029508-01, Figure 3, represented Western blots for p16\Ink4a\ and [beta]-actin expression in mN/SF, when the same images were duplicated to represent different proteins and treatments in the presentations Autophagy Pathways.ppt, RicDec.ppt, and RM.ppt. While at UM, Respondent fabricated data in R21 AG030361-01 and supporting data for the grant application in the research record, where: [ssquf] R21 AG030361-01, Figure 2, represented a Western blot for phosphorylated c-Jun-N-terminal kinase (JNK) expression in mN/SF exposed to cadmium, when the experiment was not performed. [ssquf] The research record contained ninety (90) Western blot images and ninety (90) densitometry measurement files for 45 experiments that examined phosphorylated JNK or Mitogen-activated protein kinase 4 (MMK4) expression in mN/SF exposed to UV light, H 2 O2 , cadmium, or anisomycin, when the experiments were not performed. [ssquf] The research record contained densitometric analyses for an additional twenty-eight (28) experiments that examined phosphorylated JNK or MMK4 expression in mN/SF exposed to UV light, H2 O2 , cadmium, or anisomycin, when the quantifications were based on experiments that were not performed.While at UM, Respondent falsified and/or fabricated Western blots for phosphorylated and total Rac1/cdc42 expression in mN/ SF, total JNK expression in mN/SF treated with anisomycin, phosphorylated JNK expression in Snell dwarf mice fibroblasts treated with cadmium, [beta]-actin expression in mN/SF, [beta]-actin expression in Snell dwarf mice fibroblasts treated with or without MMS, [beta]- actin expression in normal mice fibroblasts treated with cadmium, and [beta]-actin expression in mN/SF treated with H 2 O2 in the presentations Autophagy Pathway.ppt, Oct PPt.ppt, RicDec.ppt, Ricky Presentation 06.ppt, Ricky STC.ppt, and RM.ppt, and the image file Final LC 3.jpg, when the images were duplicated and falsely relabeled Western blots of unrelated experiments.While at UM, Respondent falsified twenty-four (24) Western blots for phosphorylated JNK or MMK4 expression in mN/SF exposed to UV light, H 2 O2 , cadmium, or anisomycin in the seven (7) presentations and twenty-six (26) data files in the research record, when the images were duplicated and falsely relabeled Western blots of unrelated experiments.While at UC, Respondent falsified and/or fabricated Western blots by using images from unrelated experiments and the related densitometric analyses that were based on falsified Western blots in the following: [ssquf] R01 HL102405-01 for: --Figure 1A for phosphorylated Rhodopsin (Rho) expression in neonatal rat ventricular cardiac myocytes (NRVCM) subjected to stimulation with Angiotension II (Ang II) [[Page 34358]] --Figure 1A for G protein-coupled receptor kinase-2 (GRK2) expression in NRVCM subjected to cyclical mechanical stretch --Figure 1B for densitometric analysis of GRK2 activity --Figure 2A for phosphorylated Rho and GRK2 expression in NRVCM subjected to mechanical stretch --Figure 2B for densitometric analysis of GRK2 activity --Figure 3A for phosphorylated Rho expression in NRVCM after mechanical stretch and treatment with protein kinase C (PKC) inhibitor chelerythrine (lanes 5 and 6) --Figure 3B for densitometric analyses of GRK2 activity after PKC inhibition via chelerythrine treatment [ssquf] K08 HL081472-05 Progress Report for: --Figure 1A for phosphorylated Rho and GRK2 expression in NRVCM subjected to mechanical stretch --Figure 1B for densitometric analyses of GRK2 activity after PKC inhibition via chelerythrine treatment [ssquf] JBC 2010 for: --Figure 1B for phosphorylated Rho expression in NTVCM subjected to stimulation with Ang II --Figure 1B for GRK2 expression in NRVCM subjected to cyclical mechanical stretch panel --Figure 1C for densitometric analysis of GRK2 activity --Figure 2A for phosphorylated Rho expression in NRVCM after mechanical stretch and treatment with the Ang II type 1 (AT 1 ) receptor antagonist Irbesartan (lanes 5 and 6) --Figure 2B for densitometric analyses of GRK2 activity after PKC inhibition via Irbesartan treatment --Figure 4C for phosphorylated Rho and GRK2 expression in NRVCM subjected to mechanical stretch --Figure 4D for densitometric analysis of GRK2 activity after RNAi treatment Dr. Malhotra has entered into a Voluntary Settlement Agreement with ORI, in which he voluntarily agreed to the administrative actions set forth below: (1) Respondent agreed that he had no intention in applying for or engaging in U.S. Public Health Service (PHS)-supported research or otherwise working with PHS. However, if within five (5) years of the effective date of the Agreement (May 6, 2016), Respondent receives or applies for PHS support, Respondent agreed to have his research supervised for a period of ten (10) years beginning on the date of his employment in a position in which he receives or applies for PHS support and to notify his employer/institution(s) of the terms of this supervision. (2) Respondent certified that he is not currently engaged in or receiving PHS support. Respondent agreed that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to the Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval. The supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution as outlined below. Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI. Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan. (3) The requirements for Respondent's supervision plan are as follows: i. A committee of senior faculty members and officials at the institution who are familiar with Respondent's field of research, but not including Respondent's supervisor or collaborators, will provide oversight and guidance for ten (10) years. The committee will review primary data for Respondent's PHS-supported research on a quarterly basis setting forth the committee meeting dates, Respondent's compliance with appropriate research standards, and confirming the integrity of Respondent's research. ii. The committee will conduct an advance review of any PHS grant application (including supplements, resubmissions, etc.), manuscripts reporting PHS-funded research submitted for publication, and abstracts. The review will include a discussion with Respondent of the primary data represented in those documents and will include a certification that the data presented in the proposed application/publication is supported by the research record. (4) If within five (5) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed that for a period of ten (10) years beginning on the date of his employment that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a report and certification to ORI at six (6) month intervals that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract. (5) If no supervisory plan is provided to ORI, Respondent agreed to provide certification to ORI on a quarterly basis for a period of five (5) years, beginning on May 6, 2016, that he has not engaged in, applied for, or had his name included on any application, proposal, or other request for PHS funds made available through grants, subgrants, cooperative agreements, contracts, subcontracts, supplements, awards, fellowships, projects, programs, small business technology transfer (STTR) and small business innovation research (SBIR) programs, conferences, meetings, centers, resources, studies, and trials, without prior notification to ORI. (6) Respondent agreed 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 for a period of five (5) years, beginning on May 6, 2016. (7) As a condition of the Agreement, Respondent agreed to the retraction of JBC 2010. FOR FURTHER INFORMATION CONTACT: Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200. Kathryn M. Partin, Director, Office of Research Integrity. [FR Doc. 2016-12800 Filed 5-27-16; 8:45 am] BILLING CODE 4150-31-P
![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34357
number of registrants requesting to from 2005–2006, and Research Assistant phosphorylated c-Jun-N-terminal kinase
speak is greater than can be reasonably Professor, Department of Surgery, UC, (JNK) expression in mN/SF exposed to
accommodated during the scheduled from 2007–2011, engaged in research cadmium, when the experiment was not
open public hearing session, FDA may misconduct in research supported by performed.
conduct a lottery to determine the National Heart, Lung, and Blood D The research record contained
speakers for the scheduled open public Institute (NHLBI), National Institutes of ninety (90) Western blot images and
hearing session. The contact person will Health (NIH), grants K08 HL081472 and ninety (90) densitometry measurement
notify interested persons regarding their R01 HL107949. files for 45 experiments that examined
request to speak by July 8, 2016. ORI found that falsified and/or phosphorylated JNK or Mitogen-
Persons attending FDA’s advisory fabricated data were included in the activated protein kinase 4 (MMK4)
committee meetings are advised that the following three (3) NIH grant expression in mN/SF exposed to UV
Agency is not responsible for providing applications, one (1) NIH grant progress light, H2O2, cadmium, or anisomycin,
access to electrical outlets. report, one (1) publication, seven (7) when the experiments were not
FDA welcomes the attendance of the presentations, and one (1) image file: performed.
public at its advisory committee • R03 AG029508–01 D The research record contained
meetings and will make every effort to • R21 AG030361–01 densitometric analyses for an additional
accommodate persons with disabilities. • R01 HL102405–01 twenty-eight (28) experiments that
If you require accommodations due to a • K08 HL081472–05 Progress Report examined phosphorylated JNK or
disability, please contact AnnMarie • J Biol Chem. 285(18):13748–60, 2010 MMK4 expression in mN/SF exposed to
Williams, at Annmarie.Williams@ Apr 30 (hereafter referred to as ‘‘JBC UV light, H2O2, cadmium, or
fda.hhs.gov, or 301–796–5966 at least 7 2010’’) anisomycin, when the quantifications
days in advance of the meeting. • Presentation: Autophagy were based on experiments that were
FDA is committed to the orderly Pathway.ppt, MKK4 expression after not performed.
conduct of its advisory committee UV.ppt, Oct PPt.ppt, RicDec.ppt, • While at UM, Respondent falsified
meetings. Please visit our Web site at Ricky Presentation 06.ppt, Ricky and/or fabricated Western blots for
http://www.fda.gov/ STC.ppt, and RM.ppt phosphorylated and total Rac1/cdc42
AdvisoryCommittees/ • Image file: Final LC 3.jpg expression in mN/SF, total JNK
AboutAdvisoryCommittees/ ORI found that Respondent reused expression in mN/SF treated with
ucm111462.htm for procedures on and falsely relabeled Western blot gel anisomycin, phosphorylated JNK
public conduct during advisory images, falsified the related expression in Snell dwarf mice
committee meetings. densitometry measurements based on fibroblasts treated with cadmium, b-
Notice of this meeting is given under the falsified Western blots, and falsified actin expression in mN/SF, b-actin
the Federal Advisory Committee Act (5 and/or fabricated data for experiments expression in Snell dwarf mice
U.S.C. app. 2). that were not performed. Respondent fibroblasts treated with or without
Dated: May 24, 2016. continued this falsification at UC, after MMS, b-actin expression in normal
Jill Hartzler Warner, the UM research misconduct mice fibroblasts treated with cadmium,
Associate Commissioner for Special Medical investigation was completed. and b-actin expression in mN/SF treated
Programs. Specifically: with H2O2 in the presentations
[FR Doc. 2016–12641 Filed 5–27–16; 8:45 am] • While at UM, Respondent falsified Autophagy Pathway.ppt, Oct PPt.ppt,
BILLING CODE 4164–01–P and/or fabricated images in R03 RicDec.ppt, Ricky Presentation 06.ppt,
AG029508–01 and three (3) Ricky STC.ppt, and RM.ppt, and the
presentations, where: image file Final LC 3.jpg, when the
DEPARTMENT OF HEALTH AND D R03 AG029508–01, Figure 2, images were duplicated and falsely
HUMAN SERVICES represented Western blots for relabeled Western blots of unrelated
phosphorylated p53 (Ser15) and b-actin experiments.
Office of the Secretary expression in normal and Snell dwarf • While at UM, Respondent falsified
mice fibroblasts (mN/SF) treated with twenty-four (24) Western blots for
Findings of Research Misconduct the DNA alkylating agent methyl phosphorylated JNK or MMK4
AGENCY: Office of the Secretary, HHS. methanesulfonate (MMS), when the expression in mN/SF exposed to UV
same images were duplicated to light, H2O2, cadmium, or anisomycin in
ACTION: Notice. the seven (7) presentations and twenty-
represent different proteins and
SUMMARY: Notice is hereby given that treatments in the presentations six (26) data files in the research record,
the Office of Research Integrity (ORI) Autophagy Pathway.ppt and RM.ppt. when the images were duplicated and
has taken final action in the following D R03 AG029508–01, Figure 3, falsely relabeled Western blots of
case: represented Western blots for p16Ink4a unrelated experiments.
Ricky Malhotra, Ph.D., University of and b-actin expression in mN/SF, when • While at UC, Respondent falsified
Michigan and University of Chicago: the same images were duplicated to and/or fabricated Western blots by using
Based on the Respondent’s admission to represent different proteins and images from unrelated experiments and
committing research misconduct at the treatments in the presentations the related densitometric analyses that
University of Michigan (UM) and Autophagy Pathways.ppt, RicDec.ppt, were based on falsified Western blots in
subsequently at the University of and RM.ppt. the following:
sradovich on DSK3TPTVN1PROD with NOTICES
Chicago (UC), the reports of separate • While at UM, Respondent D R01 HL102405–01 for:
investigations conducted by UM and fabricated data in R21 AG030361–01 —Figure 1A for phosphorylated
UC, and additional analysis conducted and supporting data for the grant Rhodopsin (Rho) expression in
by ORI in its oversight review, ORI application in the research record, neonatal rat ventricular cardiac
found that Dr. Ricky Malhotra, former where: myocytes (NRVCM) subjected to
Research Assistant Professor, D R21 AG030361–01, Figure 2, stimulation with Angiotension II (Ang
Department of Internal Medicine, UM, represented a Western blot for II)
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![34358 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
—Figure 1A for G protein-coupled (2) Respondent certified that he is not accurately reported in the application,
receptor kinase-2 (GRK2) expression currently engaged in or receiving PHS report, manuscript, or abstract.
in NRVCM subjected to cyclical support. Respondent agreed that prior to (5) If no supervisory plan is provided
mechanical stretch the submission of an application for to ORI, Respondent agreed to provide
—Figure 1B for densitometric analysis PHS support for a research project on certification to ORI on a quarterly basis
of GRK2 activity which the Respondent’s participation is for a period of five (5) years, beginning
—Figure 2A for phosphorylated Rho proposed and prior to the Respondent’s on May 6, 2016, that he has not engaged
and GRK2 expression in NRVCM participation in any capacity on PHS- in, applied for, or had his name
subjected to mechanical stretch supported research, Respondent shall included on any application, proposal,
—Figure 2B for densitometric analysis ensure that a plan for supervision of or other request for PHS funds made
of GRK2 activity Respondent’s duties is submitted to ORI available through grants, subgrants,
—Figure 3A for phosphorylated Rho for approval. The supervision plan must cooperative agreements, contracts,
expression in NRVCM after be designed to ensure the scientific subcontracts, supplements, awards,
mechanical stretch and treatment integrity of Respondent’s research fellowships, projects, programs, small
with protein kinase C (PKC) inhibitor contribution as outlined below. business technology transfer (STTR) and
chelerythrine (lanes 5 and 6) Respondent agreed that he shall not small business innovation research
—Figure 3B for densitometric analyses (SBIR) programs, conferences, meetings,
participate in any PHS-supported
of GRK2 activity after PKC inhibition centers, resources, studies, and trials,
research until such a supervision plan is
via chelerythrine treatment without prior notification to ORI.
submitted to and approved by ORI.
D K08 HL081472–05 Progress Report Respondent agreed to maintain (6) Respondent agreed to exclude
for: responsibility for compliance with the himself voluntarily from serving in any
—Figure 1A for phosphorylated Rho agreed upon supervision plan. advisory capacity to PHS including, but
and GRK2 expression in NRVCM (3) The requirements for Respondent’s not limited to, service on any PHS
subjected to mechanical stretch supervision plan are as follows: advisory committee, board, and/or peer
—Figure 1B for densitometric analyses review committee, or as a consultant for
i. A committee of senior faculty
of GRK2 activity after PKC inhibition a period of five (5) years, beginning on
members and officials at the institution
via chelerythrine treatment May 6, 2016.
who are familiar with Respondent’s
D JBC 2010 for: field of research, but not including
(7) As a condition of the Agreement,
—Figure 1B for phosphorylated Rho Respondent agreed to the retraction of
Respondent’s supervisor or
expression in NTVCM subjected to JBC 2010.
collaborators, will provide oversight and
stimulation with Ang II FOR FURTHER INFORMATION CONTACT:
guidance for ten (10) years. The
—Figure 1B for GRK2 expression in committee will review primary data for Director, Office of Research Integrity,
NRVCM subjected to cyclical Respondent’s PHS-supported research 1101 Wootton Parkway, Suite 750,
mechanical stretch panel on a quarterly basis setting forth the Rockville, MD 20852, (240) 453–8200.
—Figure 1C for densitometric analysis
committee meeting dates, Respondent’s Kathryn M. Partin,
of GRK2 activity
—Figure 2A for phosphorylated Rho compliance with appropriate research Director, Office of Research Integrity.
expression in NRVCM after standards, and confirming the integrity [FR Doc. 2016–12800 Filed 5–27–16; 8:45 am]
mechanical stretch and treatment of Respondent’s research. BILLING CODE 4150–31–P
with the Ang II type 1 (AT1) receptor ii. The committee will conduct an
antagonist Irbesartan (lanes 5 and 6) advance review of any PHS grant
—Figure 2B for densitometric analyses application (including supplements, DEPARTMENT OF HEALTH AND
of GRK2 activity after PKC inhibition resubmissions, etc.), manuscripts HUMAN SERVICES
via Irbesartan treatment reporting PHS-funded research
—Figure 4C for phosphorylated Rho and submitted for publication, and abstracts. National Committee on Vital and Health
GRK2 expression in NRVCM The review will include a discussion Statistics: Meeting
subjected to mechanical stretch with Respondent of the primary data AGENCY: National Committee on Vital
—Figure 4D for densitometric analysis represented in those documents and and Health Statistics (NCVHS), HHS
of GRK2 activity after RNAi treatment will include a certification that the data
ACTION: Notice of full committee and
Dr. Malhotra has entered into a presented in the proposed application/
subcommittee meetings.
Voluntary Settlement Agreement with publication is supported by the research
ORI, in which he voluntarily agreed to record. SUMMARY: Pursuant to the Federal
the administrative actions set forth (4) If within five (5) years from the Advisory Committee Act, the
below: effective date of the Agreement, Department of Health and Human
(1) Respondent agreed that he had no Respondent receives or applies for PHS Services (HHS) announces the following
intention in applying for or engaging in support, Respondent agreed that for a advisory committee meeting.
U.S. Public Health Service (PHS)- period of ten (10) years beginning on the DATES: Tuesday, June 14, 2016: 9 a.m.–
supported research or otherwise date of his employment that any 5:40 p.m.—Full Committee Meeting.
working with PHS. However, if within institution employing him shall submit, Wednesday, June 15, 2016: 8 a.m.–
five (5) years of the effective date of the in conjunction with each application for 2:25 p.m.—Full Committee Meeting.
Agreement (May 6, 2016), Respondent PHS funds, or report, manuscript, or Thursday, June 16, 2016: 8:30 a.m.–5
receives or applies for PHS support, abstract involving PHS-supported p.m.—Privacy Subcommittee Meeting
sradovich on DSK3TPTVN1PROD with NOTICES
Respondent agreed to have his research research in which Respondent is on ‘‘Minimum Necessary and the Health
supervised for a period of ten (10) years involved, a report and certification to Insurance Portability and
beginning on the date of his ORI at six (6) month intervals that the Accountability Act (HIPAA)’’.
employment in a position in which he data provided by Respondent are based Friday, June 17, 2016: 8:15 a.m.–4
receives or applies for PHS support and on actual experiments or are otherwise p.m.—NCVHS Meeting on Claims-based
to notify his employer/institution(s) of legitimately derived and that the data, Databases for Policy Development and
the terms of this supervision. procedures, and methodology are Evaluation.
VerDate Sep<11>2014 20:07 May 27, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1](https://thefederalregister.org/doc/81_FR_34461/page/2.svg)
Document Created: 2016-05-28 03:57:59
Document Modified: 2016-05-28 03:57:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Section | Notices | |
| Action | Notice. | |
| Contact | Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200. | |
| FR Citation | 81 FR 34357 |
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