Findings of Research Misconduct, 75339-75341 [2020-26100]
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75339
Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
and to describe best practices for FDA
and sponsors when interacting on these
topics. The guidance is available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/requesting-fda-feedbackcombination-products. In the Federal
Register of December 26, 2019 (84 FR
70976), we published a notice
announcing the availability of the draft
guidance that included an analysis
under the PRA and solicited public
comment on the proposed collection of
information for CPAMs. One comment
was received in support of the
collection but suggested no change in
FDA’s burden estimate.
Respondents to the information
collection are sponsors of medical
products, including combination
products. We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
Average
burden per
response
(hours)
Total annual
responses
Total hours
3.7; request for designation .................................................
Pre-RFD submissions ..........................................................
CPAMs requests ..................................................................
53
83
3
1
1
1
53
83
3
24
24
25
1,272
1,992
75
Total ..............................................................................
........................
........................
........................
........................
3339
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
For RFDs and pre-RFDs, our estimate
is based on the number of submissions
received from October 1, 2018, to
September 30, 2019. We assume 1
submission per respondent, for an
annual average of 53 RFD submissions,
and 83 pre-RFD submissions and
assume that each submission requires
an average of 24 hours to prepare and
submit to FDA.
Our estimate for CPAM requests is
based on future activity in light of the
minimal use of CPAMs to date; FDA has
received two CPAM requests since the
enactment of the Cures Act in December
2016. We estimate one CPAM request
will be received per year by each
medical product center (Center for
Biologics Evaluation and Research,
Center for Drug Evaluation and
Research, and Center for Devices and
Radiological Health). We assume it will
take sponsors approximately 25 hours to
compile and submit the recommended
information. Because we expect burden
associated with application submissions
is already captured by approved
information collection requests for drug,
biologic, and medical device
applications, respectively (approved
under OMB control numbers 0910–
0001, 0910–0338, and 0910–0231), we
do not include burden associated with
application submissions captured by
these programs in this information
collection request.
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Number of
responses per
respondent
Dated: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26062 Filed 11–24–20; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against Dr.
David J. Panka (Respondent), former
Harvard Medical School (HMS)
Instructor of Medicine, and former HMS
Associate Professor of Medicine at Beth
Israel Deaconess Medical Center
(BIDMC). Dr. Panka engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Cancer Institute
(NCI), National Institutes of Health
(NIH), grants P50 CA093683 and P50
CA101942. The administrative actions,
including supervision for a period of
three (3) years, were implemented
beginning on November 9, 2020, and are
detailed below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, Director, Office of
Research Integrity, 1101 Wootton
Parkway, Suite 240, 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:
Dr. David J. Panka, Harvard Medical
School and Beth Israel Deaconess
Medical Center: Based on the report of
an inquiry conducted by BIDMC and
HMS and additional analysis conducted
by ORI in its oversight review, ORI
found that Dr. Panka, former HMS
Instructor of Medicine, and former HMS
Associate Professor of Medicine at
SUMMARY:
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BIDMC, engaged in research misconduct
in research supported by PHS funds,
specifically NCI, NIH, grants P50
CA093683 and P50 CA101942.
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, and/or recklessly falsifying
and/or fabricating Western blot images
by selectively cutting, flipping,
reordering, and reusing the same source
images or non-correlated images to
represent different results in the
following three (3) published papers
and one (1) conference presentation:
• The Raf inhibitor BAY 43–9006
(Sorafenib) induces caspaseindependent apoptosis in melanoma
cells. Cancer Res. 2006 Feb 1;
66(3):1611–9 (hereafter referred to as
‘‘Cancer Res. 2006’’). Retraction in:
Cancer Res. 2019 Oct 15;79(20):5459.
• Differential modulatory effects of
GSK–3b and HDM2 on sorafenibinduced AIF nuclear translocation
(programmed necrosis) in melanoma.
Mol Cancer 2011 Sep 19;10:115
(hereafter referred as to ‘‘Mol Cancer
2011’’).
• Effects of HDM2 antagonism on
sunitinib resistance, p53 activation,
SDF–1 induction, and tumor infiltration
by CD11b+/Gr-1+ myeloid derived
suppressor cells. Mol Cancer 2013 Mar
5;12:17 (hereafter referred to as ‘‘Mol
Cancer 2013’’).
• Presentation #5328, ‘‘BAY 43–9006
induces apoptosis in melanoma cell
lines’’, presented during Cellular and
Molecular Biology session #63 ‘‘
(‘Apoptosis 4: Chemotherapeutic Agents
II’)’’ on April 20, 2005, at the 96th
Annual American Association for
Cancer Research (AACR) meeting, held
in Anaheim, California (hereafter
referred to as the ‘‘2005 AACR
Presentation’’).
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Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
Specifically, ORI found that
Respondent knowingly, intentionally,
and/or recklessly falsified and/or
fabricated:
• Western blot images in twelve (12)
figures of three (3) published papers and
one (1) conference presentation by
editing, reusing, and relabeling the same
source images or the non-correlated
blots to represent different results from
different experiments. Specifically:
—Respondent reused and relabeled the
same source bands to falsely
represent different protein
expression in the following two
figures in Cancer Res. 2006 and to
represent more than one lane
within a single row:
D Figure 1A, bottom row, in Cancer
Res. 2006, representing MEK
expression in A375, A2058, and SK
MEL 5 cells treated by different
doses of Bay 43–9006
D Figure 2C, bottom row, in Cancer
Res. 2006, representing the
expression of Vinculin in the same
three cell types without or with Bay
43–9006 treatment at different time
points
—Respondent reused and relabeled the
same source bands to falsely
represent different protein
expression in two figures as follows
and to represent more than one lane
within a single row:
D Figure 5, bottom row, in the 2005
AACR Presentation, representing
the expression of Total Bad in A375
cells with different treatments
D Figure 2C, second row, in Cancer
Res. 2006, representing the
expression of Bax in three different
cell types
—Respondent reused and relabeled the
bands that were used for Figure 4,
bottom row, in Cancer Res. 2006,
representing ERK expression in
A2058 cell type with different
treatments at different time points,
to falsely represent the expression
of ERK in three different cell types
in Figure 1A, second row, in Cancer
Res. 2006.
—Respondent reused and relabeled the
same source bands to falsely
represent unrelated experimental
results in two rows of Figure 3A in
Cancer Res. 2006 as follows:
D Figure 3A, fourth row, in Cancer
Res. 2006, representing the
expression of pBad ser 75 in A2058
cell type with different treatments
at different time points
D Figure 3A, seventh row, in Cancer
Res. 2006, representing pBad ser 75
expression in A375 cell type with
the same treatments and at the same
time points as the representation of
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the fourth row
—Respondent reused and relabeled the
source bands to falsely represent
unrelated experimental results in
two rows of Figure 3A in Cancer
Res. 2006 as follows:
D Figure 3A, first row, in Cancer Res.
2006, representing the expression of
pBad ser 75 in SK MEL 5 cell type
with different treatments at
different time points
D Figure 3A, eighth row, in Cancer
Res. 2006, representing pBad ser 99
expression in A375 cell type with
the same treatments and at the same
time points as the representation of
the first row
—Respondent fabricated the bands that
were used for Figure 3A, second
row, in Cancer Res. 2006,
representing the expression of pBad
ser 99 in SK MEL 5 cell type with
different treatments at different
time points by using an unrelated
image.
—Respondent reused and relabeled the
bands to falsely represent AIF
expression in mitochondria of the
three cell types with different
treatments in Figure 6A, the bottom
row, in Cancer Res. 2006, by:
D Duplicating the bands in the second
to fourth lanes to represent
mitochondria expression in A375
cell type with Bay 43–9006 (second
lane), PD 98059 (third lane), and
U0126 (fourth lane) treatments
D duplicating the band for both the
fifth and seventh lanes to represent
AIF expression in mitochondria of
A2058 cell type with no treatment
control (fifth lane) and PD 98059
treatment (seventh lane)
—Respondent reused and relabeled the
same source bands to falsely
represent different experimental
results in Figure 3A in Mol Cancer
2011 as follows:
D Figure 3A, first four lanes in the
middle row of the left panel, in Mol
Cancer 2011, representing c-myc
expression in nucleus of A375 cell
type
D Figure 3A, first four lanes in the
middle row of the right panel, in
Mol Cancer 2011, representing cmyc expression in nucleus of SK
MEL 5 cell type
—Respondent reused and relabeled the
same source bands to falsely
represent different experimental
results in Figure 5 in Mol Cancer
2011 as follows:
D Figure 5, sixth to eighth lanes of the
middle row, in Mol Cancer 2011,
representing BCL–XL expression in
A375–GSK cells with DOX
D Figure 5, last three lanes of the
middle row, in Mol Cancer 2011,
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representing BCL–XL expression in
SK MEL 5 S9A
—Respondent reused and relabeled the
unrelated source bands to falsely
represent different experimental
results in Figure 5 of Mol Cancer
2011 as follows:
D Figure 5, thirteenth to fifteenth
lanes of the top row, in Mol Cancer
2011, representing BCL2 expression
in SK MEL 5 S9A
D Figure 5, thirteenth to fifteenth
lanes of the bottom row, in Mol
Cancer 2011, representing
VINCULIN expression in SK MEL 5
S9A
—Respondent reused and relabeled the
same source bands to falsely
represent different experimental
results in Figure 1 in Mol Cancer
2013; specifically respondent:
D Reused the bands that were used for
Figure 1, fourth to fifth lanes of the
second row, in Mol Cancer 2013,
representing noxa expression in the
control group of A498 cell type, to
falsely represent noxa expression in
the sunitinib resistant group of
A498 cells in the same figure,
eleventh to twelfth lanes of the
second row
D reused the band that was used for
Figure 1, eighth lane of the second
row, in Mol Cancer 2013,
representing noxa expression in the
third sample of the sunitinib
responding group, to falsely
represent noxa expression in the
fifth sample of the sunitinib
responding group in the same
figure, tenth lane of the second row
—Respondent reused and relabeled the
same source bands to falsely
represent different experimental
results in Figure 6B in Mol Cancer
2013 as follows:
D Figure 6B, first two lanes of the
bottom row, in Mol Cancer 2013,
representing vinculin expression in
control group
D Figure 6B, eleventh and twelfth
lanes of the bottom row, in Mol
Cancer 2013, representing vinculin
expression in dox + sunitinib group
—Respondent reused and relabeled the
same source bands to falsely
represent different experimental
results in the following three
figures:
D Figure 10, second rows of both
upper and lower panels, in the 2005
AACR Presentation, representing
pSRC–Y416 expression in A2058
(upper) and A375 (lower) cell types
D Figure 4 in Cancer Res. 2006 and
Figure 6 in the 2005 AACR
Presentation, second rows of
middle and lower panels,
representing Bcl-XL expression in
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A2058 (middle) and SK MEL 5
(lower) cell types
—Respondent reused and relabeled the
same source band to falsely
represent two different
experimental results in Figure 5 in
the 2005 AACR Presentation as
follows:
D Figure 5, lane 1 of the seventh row,
in the 2005 AACR Presentation,
representing pBad ser 75 expression
at 0 hour in control group
D Figure 5, lane 2 of the seventh row,
in the 2005 AACR Presentation,
representing pBad ser 75 expression
at 1 hour in control group
Dr. Panka entered into a Voluntary
Settlement Agreement and agreed to the
following:
(1) Respondent agreed to have his
research supervised for a period of three
(3) years beginning on November 9,
2020. Respondent agrees that prior to
the submission of an application for
PHS support for a research project on
which Respondent’s participation is
proposed and prior to Respondent’s
participation in any capacity on PHSsupported 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. Respondent agrees that he
shall not participate in any PHSsupported research until such a
supervision plan is submitted to and
approved by ORI. Respondent agrees to
maintain responsibility for compliance
with the agreed upon supervision plan.
(2) The requirements for Respondent’s
supervision plan are as follows:
i. A committee of 2–3 senior faculty
members 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 a period of three (3) years
from the effective date of the
Agreement. The committee will review
primary data from Respondent’s
laboratory on a quarterly basis and
submit a report to ORI at six (6) month
intervals, setting forth the committee
meeting dates and 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
applications (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
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will include a certification to ORI that
the data presented in the proposed
application/publication are supported
by the research record.
(3) Respondent agreed that for a
period of three (3) years beginning on
November 9, 2020, any institution
employing him shall submit, in
conjunction with each application of
PHS funds, or report, manuscript, or
abstract involving PHS-supported
research in which Respondent is
involved, a certification to ORI 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.
(4) If no supervisory plan is provided
to ORI, Respondent agreed to provide
certification to ORI at the conclusion of
the supervision period that he has not
engaged in, applied for, or had his name
included on any application, proposal,
or other request for PHS funds without
prior notification to ORI.
(5) 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 three (3) years, beginning on
November 9, 2020.
(6) As a condition of the Agreement,
Respondent will request that the
following papers and conference
abstract be corrected or retracted in
accordance with 42 CFR 93.407(a)(1)
and § 93.411(b):
• Mol Cancer 2011 Sep 19;10:115
• Mol Cancer 2013 Mar 5;12:17
• 2005 AACR Presentation
Respondent will copy ORI and the
Research Integrity Officer at HMS and
BIDMC on the correspondence.
75341
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Neuroscience, Biomarkers and
Therapeutics.
Date: December 7, 2020.
Time: 1:00 p.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Joseph G. Rudolph, Ph.D.,
Chief and Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7844, Bethesda, MD 20892, (301) 408–
9098, josephru@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 19, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–26030 Filed 11–24–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 20, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office
of the Assistant Secretary for Health.
National Institutes of Health
[FR Doc. 2020–26100 Filed 11–24–20; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
General Medical Sciences Council.
The meeting will be open to the
public as indicated below, with a short
public comment period at the end. The
open session will be videocast and can
be accessed from the NIH Videocasting
and Podcasting website (https://
videocast.nih.gov).
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review: Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
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National Institute of General Medical
Sciences: Notice of Meeting
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]]>Agencies
[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75339-75341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Findings of research misconduct have been made against Dr.
David J. Panka (Respondent), former Harvard Medical School (HMS)
Instructor of Medicine, and former HMS Associate Professor of Medicine
at Beth Israel Deaconess Medical Center (BIDMC). Dr. Panka engaged in
research misconduct in research supported by U.S. Public Health Service
(PHS) funds, specifically National Cancer Institute (NCI), National
Institutes of Health (NIH), grants P50 CA093683 and P50 CA101942. The
administrative actions, including supervision for a period of three (3)
years, were implemented beginning on November 9, 2020, and are detailed
below.
FOR FURTHER INFORMATION CONTACT: Elisabeth A. Handley, Director, Office
of Research Integrity, 1101 Wootton Parkway, Suite 240, 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:
Dr. David J. Panka, Harvard Medical School and Beth Israel
Deaconess Medical Center: Based on the report of an inquiry conducted
by BIDMC and HMS and additional analysis conducted by ORI in its
oversight review, ORI found that Dr. Panka, former HMS Instructor of
Medicine, and former HMS Associate Professor of Medicine at BIDMC,
engaged in research misconduct in research supported by PHS funds,
specifically NCI, NIH, grants P50 CA093683 and P50 CA101942.
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, and/or recklessly falsifying and/or
fabricating Western blot images by selectively cutting, flipping,
reordering, and reusing the same source images or non-correlated images
to represent different results in the following three (3) published
papers and one (1) conference presentation:
The Raf inhibitor BAY 43-9006 (Sorafenib) induces caspase-
independent apoptosis in melanoma cells. Cancer Res. 2006 Feb 1;
66(3):1611-9 (hereafter referred to as ``Cancer Res. 2006'').
Retraction in: Cancer Res. 2019 Oct 15;79(20):5459.
Differential modulatory effects of GSK-3b and HDM2 on
sorafenib-induced AIF nuclear translocation (programmed necrosis) in
melanoma. Mol Cancer 2011 Sep 19;10:115 (hereafter referred as to ``Mol
Cancer 2011'').
Effects of HDM2 antagonism on sunitinib resistance, p53
activation, SDF-1 induction, and tumor infiltration by CD11b+/Gr-1+
myeloid derived suppressor cells. Mol Cancer 2013 Mar 5;12:17
(hereafter referred to as ``Mol Cancer 2013'').
Presentation #5328, ``BAY 43-9006 induces apoptosis in
melanoma cell lines'', presented during Cellular and Molecular Biology
session #63 `` (`Apoptosis 4: Chemotherapeutic Agents II')'' on April
20, 2005, at the 96th Annual American Association for Cancer Research
(AACR) meeting, held in Anaheim, California (hereafter referred to as
the ``2005 AACR Presentation'').
[[Page 75340]]
Specifically, ORI found that Respondent knowingly, intentionally,
and/or recklessly falsified and/or fabricated:
Western blot images in twelve (12) figures of three (3)
published papers and one (1) conference presentation by editing,
reusing, and relabeling the same source images or the non-correlated
blots to represent different results from different experiments.
Specifically:
--Respondent reused and relabeled the same source bands to falsely
represent different protein expression in the following two figures in
Cancer Res. 2006 and to represent more than one lane within a single
row:
[ssquf] Figure 1A, bottom row, in Cancer Res. 2006, representing
MEK expression in A375, A2058, and SK MEL 5 cells treated by different
doses of Bay 43-9006
[ssquf] Figure 2C, bottom row, in Cancer Res. 2006, representing
the expression of Vinculin in the same three cell types without or with
Bay 43-9006 treatment at different time points
--Respondent reused and relabeled the same source bands to falsely
represent different protein expression in two figures as follows and to
represent more than one lane within a single row:
[ssquf] Figure 5, bottom row, in the 2005 AACR Presentation,
representing the expression of Total Bad in A375 cells with different
treatments
[ssquf] Figure 2C, second row, in Cancer Res. 2006, representing
the expression of Bax in three different cell types
--Respondent reused and relabeled the bands that were used for Figure
4, bottom row, in Cancer Res. 2006, representing ERK expression in
A2058 cell type with different treatments at different time points, to
falsely represent the expression of ERK in three different cell types
in Figure 1A, second row, in Cancer Res. 2006.
--Respondent reused and relabeled the same source bands to falsely
represent unrelated experimental results in two rows of Figure 3A in
Cancer Res. 2006 as follows:
[ssquf] Figure 3A, fourth row, in Cancer Res. 2006, representing
the expression of pBad ser 75 in A2058 cell type with different
treatments at different time points
[ssquf] Figure 3A, seventh row, in Cancer Res. 2006, representing
pBad ser 75 expression in A375 cell type with the same treatments and
at the same time points as the representation of the fourth row
--Respondent reused and relabeled the source bands to falsely represent
unrelated experimental results in two rows of Figure 3A in Cancer Res.
2006 as follows:
[ssquf] Figure 3A, first row, in Cancer Res. 2006, representing the
expression of pBad ser 75 in SK MEL 5 cell type with different
treatments at different time points
[ssquf] Figure 3A, eighth row, in Cancer Res. 2006, representing
pBad ser 99 expression in A375 cell type with the same treatments and
at the same time points as the representation of the first row
--Respondent fabricated the bands that were used for Figure 3A, second
row, in Cancer Res. 2006, representing the expression of pBad ser 99 in
SK MEL 5 cell type with different treatments at different time points
by using an unrelated image.
--Respondent reused and relabeled the bands to falsely represent AIF
expression in mitochondria of the three cell types with different
treatments in Figure 6A, the bottom row, in Cancer Res. 2006, by:
[ssquf] Duplicating the bands in the second to fourth lanes to
represent mitochondria expression in A375 cell type with Bay 43-9006
(second lane), PD 98059 (third lane), and U0126 (fourth lane)
treatments
[ssquf] duplicating the band for both the fifth and seventh lanes
to represent AIF expression in mitochondria of A2058 cell type with no
treatment control (fifth lane) and PD 98059 treatment (seventh lane)
--Respondent reused and relabeled the same source bands to falsely
represent different experimental results in Figure 3A in Mol Cancer
2011 as follows:
[ssquf] Figure 3A, first four lanes in the middle row of the left
panel, in Mol Cancer 2011, representing c-myc expression in nucleus of
A375 cell type
[ssquf] Figure 3A, first four lanes in the middle row of the right
panel, in Mol Cancer 2011, representing c-myc expression in nucleus of
SK MEL 5 cell type
--Respondent reused and relabeled the same source bands to falsely
represent different experimental results in Figure 5 in Mol Cancer 2011
as follows:
[ssquf] Figure 5, sixth to eighth lanes of the middle row, in Mol
Cancer 2011, representing BCL-XL expression in A375-GSK cells with DOX
[ssquf] Figure 5, last three lanes of the middle row, in Mol Cancer
2011, representing BCL-XL expression in SK MEL 5 S9A
--Respondent reused and relabeled the unrelated source bands to falsely
represent different experimental results in Figure 5 of Mol Cancer 2011
as follows:
[ssquf] Figure 5, thirteenth to fifteenth lanes of the top row, in
Mol Cancer 2011, representing BCL2 expression in SK MEL 5 S9A
[ssquf] Figure 5, thirteenth to fifteenth lanes of the bottom row,
in Mol Cancer 2011, representing VINCULIN expression in SK MEL 5 S9A
--Respondent reused and relabeled the same source bands to falsely
represent different experimental results in Figure 1 in Mol Cancer
2013; specifically respondent:
[ssquf] Reused the bands that were used for Figure 1, fourth to
fifth lanes of the second row, in Mol Cancer 2013, representing noxa
expression in the control group of A498 cell type, to falsely represent
noxa expression in the sunitinib resistant group of A498 cells in the
same figure, eleventh to twelfth lanes of the second row
[ssquf] reused the band that was used for Figure 1, eighth lane of
the second row, in Mol Cancer 2013, representing noxa expression in the
third sample of the sunitinib responding group, to falsely represent
noxa expression in the fifth sample of the sunitinib responding group
in the same figure, tenth lane of the second row
--Respondent reused and relabeled the same source bands to falsely
represent different experimental results in Figure 6B in Mol Cancer
2013 as follows:
[ssquf] Figure 6B, first two lanes of the bottom row, in Mol Cancer
2013, representing vinculin expression in control group
[ssquf] Figure 6B, eleventh and twelfth lanes of the bottom row, in
Mol Cancer 2013, representing vinculin expression in dox + sunitinib
group
--Respondent reused and relabeled the same source bands to falsely
represent different experimental results in the following three
figures:
[ssquf] Figure 10, second rows of both upper and lower panels, in
the 2005 AACR Presentation, representing pSRC-Y416 expression in A2058
(upper) and A375 (lower) cell types
[ssquf] Figure 4 in Cancer Res. 2006 and Figure 6 in the 2005 AACR
Presentation, second rows of middle and lower panels, representing Bcl-
XL expression in
[[Page 75341]]
A2058 (middle) and SK MEL 5 (lower) cell types
--Respondent reused and relabeled the same source band to falsely
represent two different experimental results in Figure 5 in the 2005
AACR Presentation as follows:
[ssquf] Figure 5, lane 1 of the seventh row, in the 2005 AACR
Presentation, representing pBad ser 75 expression at 0 hour in control
group
[ssquf] Figure 5, lane 2 of the seventh row, in the 2005 AACR
Presentation, representing pBad ser 75 expression at 1 hour in control
group
Dr. Panka entered into a Voluntary Settlement Agreement and agreed
to the following:
(1) Respondent agreed to have his research supervised for a period
of three (3) years beginning on November 9, 2020. Respondent agrees
that prior to the submission of an application for PHS support for a
research project on which Respondent's participation is proposed and
prior to 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. Respondent agrees that he shall not
participate in any PHS-supported research until such a supervision plan
is submitted to and approved by ORI. Respondent agrees to maintain
responsibility for compliance with the agreed upon supervision plan.
(2) The requirements for Respondent's supervision plan are as
follows:
i. A committee of 2-3 senior faculty members 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 a period of three (3) years from the effective date of the
Agreement. The committee will review primary data from Respondent's
laboratory on a quarterly basis and submit a report to ORI at six (6)
month intervals, setting forth the committee meeting dates and
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
applications (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 to
ORI that the data presented in the proposed application/publication are
supported by the research record.
(3) Respondent agreed that for a period of three (3) years
beginning on November 9, 2020, any institution employing him shall
submit, in conjunction with each application of PHS funds, or report,
manuscript, or abstract involving PHS-supported research in which
Respondent is involved, a certification to ORI 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.
(4) If no supervisory plan is provided to ORI, Respondent agreed to
provide certification to ORI at the conclusion of the supervision
period that he has not engaged in, applied for, or had his name
included on any application, proposal, or other request for PHS funds
without prior notification to ORI.
(5) 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 three (3) years, beginning on November
9, 2020.
(6) As a condition of the Agreement, Respondent will request that
the following papers and conference abstract be corrected or retracted
in accordance with 42 CFR 93.407(a)(1) and Sec. 93.411(b):
Mol Cancer 2011 Sep 19;10:115
Mol Cancer 2013 Mar 5;12:17
2005 AACR Presentation
Respondent will copy ORI and the Research Integrity Officer at HMS and
BIDMC on the correspondence.
Dated: November 20, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2020-26100 Filed 11-24-20; 8:45 am]
BILLING CODE 4150-31-P
