Findings of Research Misconduct, 80122-80123 [2020-27309]
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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
each of the objectives proposed during
the entire period of performance. The
current standardized format and data
submission by applicants increases
efficiency in reviewing, awarding, and
monitoring each project.
This revision to the clearance package
will incorporate an additional form for
participants, the QPU. The QPU is
completed via HRSA’s Electronic
Handbook and prompts recipients to
report on progress of activities that were
submitted using the SWP in the original
application. The QPU will automatically
populate activities from the recipient’s
SWP form on a quarterly basis. For each
activity listed in the submitted SWP for
any particular quarter within the project
period, recipients will select and submit
a single selection response for each
activity status from a pull-down menu
with five options: Activity is on
Schedule, Activity is Complete, Timing
is off track, Activity will be missed if
action is not taken, and Activity cannot
be achieved. Information provided will
be utilized by the program staff to
regularly assess overall progress of
program requirements and analyze data
in order to monitor award recipient
compliance and track progress against
proposed targets and goals. Information
gathered will allow for an improved and
more efficient method for identifying
whether projects’ goals are being
advanced or achieved, as set forth in 45
CFR 75.342. Program staff will also use
information provided over the period of
performance to see emerging trends and
to assess whether an award recipient
requires technical assistance to address
challenges that the award recipient may
be experiencing with the
implementation of the project. Seeking
OMB approval comports with the
regulatory requirement imposed by 45
CFR 75.206(a), Paperwork clearances.
Likely Respondents: Recipients of
HRSA Bureau of Health Workforce’s
research and training grants and
cooperative agreements.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average burden per response (in
hours)
Number of respondents
Number of responses per
respondent
Standardized Work Plan (SWP) ..........................................
Quarterly Progress Update (QPU) Form .............................
1,000
1,000
1
4
1,000
4,000
1.00
.10
1,000
400
Total ..............................................................................
1 1,000
¥
5,000
¥
1,400
Form name
Total responses
Total annual
burden hours
1 The
1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active grants.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–27318 Filed 12–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
SUMMARY:
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00:32 Dec 11, 2020
Jkt 253001
Charles A. Downs (Respondent), former
Adjunct Assistant Professor, Arizona
Health Sciences Center, University of
Arizona (UA). Respondent engaged in
research misconduct in research
supported by U.S. Public Health Service
(PHS) funds, specifically National
Center for Advancing Translation
Sciences (NCATS), National Institutes of
Health (NIH), grant UL1 TR000454. The
administrative actions, including
supervision for a period of four (4)
years, were implemented beginning on
November 18, 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:
Charles A. Downs, University of
Arizona: Based on the report of an
investigation conducted by UA and
analysis conducted by ORI in its
oversight review, ORI found that
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Respondent, former Adjunct Assistant
Professor, Arizona Health Sciences
Center, UA, engaged in research
misconduct in research supported by
PHS funds, specifically NCATS, NIH,
grant UL1 TR000454.
Respondent neither admits nor denies
ORI’s findings of research misconduct.
Respondent and ORI desire to close this
matter without further expense of time
and other resources and thus have
entered into a Voluntary Settlement
Agreement (Agreement).
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying and/
or fabricating data included in the
following six (6) grant applications
submitted for PHS funds:
• R01 NR016242–01, submitted to the
National Institute of Nursing Research
(NINR), NIH
• R01 NR016242–01A1, submitted to
NINR, NIH
• R01 NR016957–01, submitted to
NINR, NIH
• R01 NR016957–01A1, submitted to
NINR, NIH
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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
• R01 HL142576–01, submitted to
National Heart, Lung, and Blood
Institute (NHLBI), NIH
• R01 NR016957–02, submitted to
NINR, NIH
ORI found that Respondent
knowingly, intentionally, or recklessly
falsified and/or fabricated histological
images and bar graphs of fluorescent
signal data for the production of reactive
oxygen species (ROS) in rat lung tissue
slices and isolated alveolar type-2 cells
by reusing and relabeling previously
published figures to represent results
from different experiments in twelve
(12) figures and related text included in
six (6) grant applications. Specifically,
Respondent falsified data in:
• Figures 4 and 5 in R01 NR016242–01
• Figures 2 and 3 in R01 NR016242–
01A1
• Figures 3A and 3B in R01 NR016957–
01
• Figures 3A and 3B in R01 NR016957–
01A1
• Figures 3A and 3B in R01 HL142576–
01
• Figures 3A and 3B in R01 NR016957–
02
Respondent entered into an
Agreement and agreed to the following:
(1) Respondent agreed to have his
research supervised for a period of four
(4) years beginning on November 18,
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 four (4) 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
VerDate Sep<11>2014
23:25 Dec 10, 2020
Jkt 253001
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 four (4) years beginning on
November 18, 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 four (4) years, beginning on
November 9, 2020.
Dated: December 8, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office
of the Assistant Secretary for Health.
[FR Doc. 2020–27309 Filed 12–10–20; 8:45 am]
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80123
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection: 60-Day Comment
Request; Generic Clearance to Support
the Safe to Sleep® Campaign at the
Eunice Kennedy Shriver National
Institute for Child Health and Human
Development
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATE: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Lorena Kaplan, M.P.H., CHES,
Office of Communications, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
National Institutes of Health, 31 Center
Drive, Room 2A32, Bethesda, Maryland
20892, or call non-toll free number (301)
496–6670 or Email your request,
including your address to
lorena.kaplan@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80122-80123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27309]
-----------------------------------------------------------------------
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 Charles
A. Downs (Respondent), former Adjunct Assistant Professor, Arizona
Health Sciences Center, University of Arizona (UA). Respondent engaged
in research misconduct in research supported by U.S. Public Health
Service (PHS) funds, specifically National Center for Advancing
Translation Sciences (NCATS), National Institutes of Health (NIH),
grant UL1 TR000454. The administrative actions, including supervision
for a period of four (4) years, were implemented beginning on November
18, 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:
Charles A. Downs, University of Arizona: Based on the report of an
investigation conducted by UA and analysis conducted by ORI in its
oversight review, ORI found that Respondent, former Adjunct Assistant
Professor, Arizona Health Sciences Center, UA, engaged in research
misconduct in research supported by PHS funds, specifically NCATS, NIH,
grant UL1 TR000454.
Respondent neither admits nor denies ORI's findings of research
misconduct. Respondent and ORI desire to close this matter without
further expense of time and other resources and thus have entered into
a Voluntary Settlement Agreement (Agreement).
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, or recklessly falsifying and/or fabricating
data included in the following six (6) grant applications submitted for
PHS funds:
R01 NR016242-01, submitted to the National Institute of
Nursing Research (NINR), NIH
R01 NR016242-01A1, submitted to NINR, NIH
R01 NR016957-01, submitted to NINR, NIH
R01 NR016957-01A1, submitted to NINR, NIH
[[Page 80123]]
R01 HL142576-01, submitted to National Heart, Lung, and Blood
Institute (NHLBI), NIH
R01 NR016957-02, submitted to NINR, NIH
ORI found that Respondent knowingly, intentionally, or recklessly
falsified and/or fabricated histological images and bar graphs of
fluorescent signal data for the production of reactive oxygen species
(ROS) in rat lung tissue slices and isolated alveolar type-2 cells by
reusing and relabeling previously published figures to represent
results from different experiments in twelve (12) figures and related
text included in six (6) grant applications. Specifically, Respondent
falsified data in:
Figures 4 and 5 in R01 NR016242-01
Figures 2 and 3 in R01 NR016242-01A1
Figures 3A and 3B in R01 NR016957-01
Figures 3A and 3B in R01 NR016957-01A1
Figures 3A and 3B in R01 HL142576-01
Figures 3A and 3B in R01 NR016957-02
Respondent entered into an Agreement and agreed to the following:
(1) Respondent agreed to have his research supervised for a period
of four (4) years beginning on November 18, 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 four (4) 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 four (4) years beginning
on November 18, 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 four (4) years, beginning on November
9, 2020.
Dated: December 8, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2020-27309 Filed 12-10-20; 8:45 am]
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