[Federal Register Volume 88, Number 129 (Friday, July 7, 2023)]
[Notices]
[Pages 43363-43364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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'').
     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.
     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.
     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.
     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.
     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'').
     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]]

     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'').
     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).
     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'').
     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.
     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.
     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.
     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:
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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:
     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]
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