Notice2023-14426
Findings of Research Misconduct
Primary source
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Published
July 7, 2023
Issuing agencies
Health and Human Services Department
Abstract
Findings of research misconduct have been made against William M. Armstead, Ph.D. (Respondent), who was a Research Associate Professor of Anesthesiology and Critical Care, Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania (UPENN). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH), grants R01 NS090998-01A1, R21 NS095321, and T32 NS043126 and National Institute of Child Health and Human Development (NICHD), NIH, grant R01 HD057355. The research was included in grant applications for PHS funds, specifically R35 NS116805-01, R01 NS121149-01, and R01 NS090998-02, -03, -04, and -05 submitted to NINDS, NIH, and R01 HL139506-01 submitted to the National Heart, Lung, and Blood Institute (NHLBI), NIH. The administrative actions, including debarment for a period of seven (7) years, were implemented beginning on June 19, 2023, and are detailed below.
Full Text
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<title>Federal Register, Volume 88 Issue 129 (Friday, July 7, 2023)</title>
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[Federal Register Volume 88, Number 129 (Friday, July 7, 2023)]
[Notices]
[Pages 43363-43364]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14426]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: Findings of research misconduct have been made against William
M. Armstead, Ph.D. (Respondent), who was a Research Associate Professor
of Anesthesiology and Critical Care, Department of Anesthesiology and
Critical Care, Perelman School of Medicine, University of Pennsylvania
(UPENN). Respondent engaged in research misconduct in research
supported by U.S. Public Health Service (PHS) funds, specifically
National Institute of Neurological Diseases and Stroke (NINDS),
National Institutes of Health (NIH), grants R01 NS090998-01A1, R21
NS095321, and T32 NS043126 and National Institute of Child Health and
Human Development (NICHD), NIH, grant R01 HD057355. The research was
included in grant applications for PHS funds, specifically R35
NS116805-01, R01 NS121149-01, and R01 NS090998-02, -03, -04, and -05
submitted to NINDS, NIH, and R01 HL139506-01 submitted to the National
Heart, Lung, and Blood Institute (NHLBI), NIH. The administrative
actions, including debarment for a period of seven (7) years, were
implemented beginning on June 19, 2023, and are detailed below.
FOR FURTHER INFORMATION CONTACT: Sheila Garrity, JD, MPH, MBA,
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:
William M. Armstead, Ph.D., University of Pennsylvania: Based on
the report of an investigation conducted by UPENN and additional
analysis conducted by ORI in its oversight review, ORI found that
William M. Armstead, Ph.D., former Research Associate Professor of
Anesthesiology and Critical Care, Department of Anesthesiology and
Critical Care, Perelman School of Medicine, UPENN, engaged in research
misconduct in research supported by PHS funds, specifically NINDS, NIH,
grants R01 NS090998-01A1, R21 NS095321, and T32 NS043126 and NICHD,
NIH, grant R01 HD057355. The research was included in grant
applications for PHS funds, specifically R35 NS116805-01, R01 NS121149-
01, and R01 NS090998-02, -03, -04, and -05 submitted to NINDS, NIH, and
R01 HL139506-01 submitted to NHLBI, NIH.
ORI found that Respondent engaged in research misconduct by
knowingly and intentionally falsifying and/or fabricating fifty-one
(51) figures and the methods, data, results, and conclusions reporting
on the effects of various vasoactive agents on the neurologic response
to traumatic brain injury in piglets of different ages and genders in
the following five (5) published papers, one (1) unpublished
manuscript, one (1) review article, three (3) posters, three (3) grant
applications submitted for PHS funds, and four (4) NIH grant progress
reports:
<bullet> Dopamine protects cerebral autoregulation and prevents
hippocampal necrosis after traumatic brain injury via block of ERK MAP
in juvenile pigs. Brain Res. 2017 Sep 1;1670:118-24. Epub 2017 Jun 15.
doi: 10.1016/j.brainres.2017.06.010 (hereafter referred to as ``Brain
Res. 2017'').
<bullet> Sex and Age Differences in Epinephrine Mechanisms and
Outcomes after Brain Injury. J Neurotrauma 2017 Apr 15;34(8):1666-75.
Epub 2017 Jan 13. doi: 10.1089/neu.2016/4770 (hereafter referred to as
``J Neurotrauma 2017''). Retraction in: J Neurotrauma 2022 Jun;39(11-
12):894. doi: 10.1089/neu.2016.4770.retract.
<bullet> Sex and age differences in phenylephrine mechanisms and
outcomes after piglet brain injury. Pediatr Res. 2017 Jul;82(1):108-13.
Epub 2017 Apr 26. doi:10.1038/pr.2017.83 (hereafter referred to as
``Pediatr Res. 2017''). Retraction in Pediatr Res. 2022 Oct:92
(4):1200. doi:10.1038/s41390-022-02248-9.
<bullet> Norepinephrine Protects Cerebral Autoregulation and
Reduces Hippocampal Necrosis after Traumatic Brain Injury via Blockade
of ERK MAPK and IL-6 in Juvenile Pigs. J Neurotrauma. 2016 Oct
1;33(19):1761-67. Epub 2016 Mar 22. doi: 10.1089/neu.2015.4290
(hereafter referred to as ``J Neurotrauma 2016''). Retraction in: J
Neurotrauma. 2022 Jun;39(11-12):893. doi:neu.2015.4290.retract.
<bullet> Preferential Protection of Cerebral Autoregulation and
Reduction of Hippocampal Necrosis with Norepinephrine After Traumatic
Brain Injury in Female Piglets. Ped Crit Care Med. 2016 Mar;17(3):e
130-7. doi: 10.1097/PCC.0000000000000603 (hereafter referred to as
``Ped Crit Care Med. 2016''). Retraction in: Ped Crit Care Med. 2022
Jul 1; 23(7):e371. doi: 10.1097/PCC.0000000000003014.
<bullet> Manuscript: Phenylephrine modulates CSF IL-6 in a sex-
dependent manner to protect cerebral autoregulation and reduce neuronal
death after traumatic brain injury in newborn pigs. Submitted to
Pediatric Critical Care Medicine in 2019. Withdrawn (hereafter referred
to as the ``Ped Crit Care Med 2019 manuscript'').
<bullet> Review article: Translational approach towards determining
the role of cerebral autoregulation in outcome after traumatic brain
injury. Exp Neurol. 2019 Jul;317:291-7. doi: 10.1016/
j.expneurol.2019.03.015 (hereafter referred to as ``Exp Neurol.
2019'').
[[Page 43364]]
<bullet> Poster: Normalization of CPP after TBI protects
autoregulation and hippocampal neuronal cell necrosis in female but not
male piglets via block of ERK MAPK and IL-6 upregulation. 43rd Society
for Neuroscience in Anesthesiology and Critical Care (SNACC) Annual
Meeting, San Diego, CA, October 22-23, 2015 (hereafter referred to as
the ``SNACC 2015 poster'').
<bullet> Poster: Norepinephrine protects cerebral autoregulation
and reduces hippocampal necrosis after traumatic brain injury via block
of ERK MAPK and IL-6 in juvenile pigs. Experimental Biology Annual
Meeting, San Diego, CA, April 2-6, 2016 (hereafter referred to as the
``Experimental Biology 2016 poster).
<bullet> Poster: Epinephrine blocks JNK MAPK, protects
autoregulation and reduces histopathology after brain injury by age and
sex. Neurotrauma 2016--The 34th Annual Symposium of the National
Neurotrauma Society, Lexington, KY, June 26-29, 2016 (hereafter
referred to as the ``Neurotrauma Society 2016 poster'').
<bullet> R35 NS116805-01, ``Brain-heart relationships in outcomes
after traumatic brain injury,'' submitted to NINDS, NIH, on July 26,
2019, administratively withdrawn on March 3, 2020.
<bullet> R01 NS121149-01, ``Brain Heart Interactions and Vascular
Contribution to Cognitive Outcome After TBI,'' submitted to NINDS, NIH,
on June 5, 2020, administratively withdrawn on November 1, 2022.
<bullet> R01 HL139506-01, ``tPA, NMDA receptor excitotoxicity, and
outcome after stroke,'' submitted to NHLBI, NIH, on February 6, 2017,
administratively withdrawn on July 2, 2019.
<bullet> NINDS, NIH, R01 NS090998-02, -03, -04, and -05 grant
progress reports, ``Pressor Choice Influences Protection of
Autoregulation in Brain Injury,'' Funding Period: September 1, 2015-
August 31, 2020.
Specifically, ORI found that Respondent intentionally and
knowingly:
<bullet> Reused histopathology slides to falsely represent the
controls for hippocampal neurons exposed to fluid percussion injury
(FPI) and treated with norepinephrine (NE), phenylephrine (PHE),
epinephrine (EPI), or dopamine (DA) in distinct experiments performed
at different times in Figures 7A, 7B, 7C, 7E, 7G, and 7H of Ped Crit
Care Med. 2016, Figures 5A, 5B, 5C, 5D, 5G, and 5H of the Ped Crit Cre
Med. 2019 manuscript, Figures 5A, 5B, 5C, 5E, 5G, and 5H of Pediatr
Res. 2017, Figures 6A, 6B, 6C, 6G, and 6H of J Neurotrauma 2017,
Figures 7A, 7B, 7C, and 7E of J Neurotrauma 2016, and Figures 5A, 5B,
5C, 5D, and 5E of Brain Res. 2017.
<bullet> Reused the histopathology slides representing necrotic
neurons after FPI treatment with NE in Figure 7E of Ped Crit Care Med.
2016 and relabeled the panel to falsely represent necrotic neurons
after FPI treatment with PHE in Figure 5D of the Ped Crit Care Med.
2019 manuscript.
<bullet> Reused and relabeled the histograms to falsely represent
traumatic brain injury responses, as represented by necrotic
hippocampal neurons, in piglets of different ages and/or genders
exposed to different therapeutic agents in Figure 5I of the Ped Crit
Care Med. 2019 manuscript, Figure 7I of Ped Crit Care Med. 2016, Figure
7G of J Neurotrauma 2016, Figure 7G of J Neurotrauma 2017, and Figure
5I of Brain Res. 2017.
<bullet> Reused and relabeled histograms to falsely represent the
pial artery response to different therapeutic agents for traumatic
brain injury in piglets of different ages and genders in Figure 3 of
Pediatr Res. 2017, Figures 3A and 3B of Ped Crit Care Med. 2016, and
Figures 3 and 5I of Brain Res. 2017.
<bullet> Falsified and/or fabricated the sham condition,
experimental methods, neuronal count methodology, piglet number, data,
and statistics reported in Ped Crit Care Med. 2016, J Neurotrauma 2016,
J Neurotrauma 2017, Pediatr Res. 2017, Brain Res. 2017, and the Ped
Crit Care Med. 2019 manuscript.
<bullet> Reported falsified data, results, and conclusions
highlighting the roles that age and gender have in the treatment of
traumatic brain injury from Ped Crit Care Med 2016, J Neurotrauma 2016,
J Neurotrauma 2017, Brain Res. 2017, and Pediatr Res. 2017 in Exp.
Neuro 2019.
<bullet> Reported falsified results from Ped Crit Care Med. 2016, J
Neurotrauma 2016, J Neurotrauma 2017, and Brain Res. 2017 and in the
SNACC 2016 poster, Experimental Biology 2016 poster, Neurotrauma 2016
poster in progress reports R01 NS090998-02, -03, -04, and -05.
<bullet> Reported falsified results of the vasoactive agents NE,
EPI, PHE, and DA on autoregulation and hippocampal neuronal necrosis in
piglets of different ages and genders after a stroke or traumatic brain
injury in Figures 4A, 4B, 5A, 5B, 6A, and 6B of R35 NS116805-01 and R01
NS121149-01, Figures 3A, 3B, 3G, and 3H of R01 HL139506-01, and the
Research Strategy section of R35 NS116805-01.
Respondent entered into a Voluntary Exclusion Agreement (Agreement)
and voluntarily agreed to the following:
(1) Respondent will exclude himself voluntarily for a period of
seven (7) years beginning on June 19, 2023 (the ``Exclusion Period''),
from any contracting or subcontracting with any agency of the United
States Government and from eligibility for or involvement in
nonprocurement or procurement transactions referred to as ``covered
transactions'' in 2 CFR parts 180 and 376 (collectively the ``Debarment
Regulations'').
(2) During the Exclusion Period, Respondent will exclude himself
voluntarily from serving in any advisory or consultant capacity to PHS
including, but not limited to, service on any PHS advisory committee,
board, and/or peer review committee.
(3) Respondent will request that the following paper be corrected
or retracted:
<bullet> Exp Neurol. 2019 Jul;317:291-7. doi: 10.1016/
j.expneurol.2019.03.015.
Respondent will copy ORI and the Research Integrity Officer at
UPENN on the correspondence with the journal.
Dated: July 3, 2023.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2023-14426 Filed 7-6-23; 8:45 am]
BILLING CODE 4150-31-P
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