Notice2024-12167
Findings of Research Misconduct
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 4, 2024
Issuing agencies
Health and Human Services Department
Abstract
Findings of research misconduct have been made against Shaker Mousa, Ph.D., M.B.A., FACC, FACB (Respondent), who was a Professor, Chairman, and Executive Vice President of the Pharmaceutical Research Institute, Albany College of Pharmacy and Health Sciences (ACPHS). Respondent 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), grant R21 CA135245 and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R01 DK052798. The administrative actions, including supervision for a period of four (4) years, were implemented beginning on May 15, 2024, and are detailed below.
Full Text
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<title>Federal Register, Volume 89 Issue 108 (Tuesday, June 4, 2024)</title>
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[Federal Register Volume 89, Number 108 (Tuesday, June 4, 2024)]
[Notices]
[Pages 47968-47969]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12167]
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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 Shaker
Mousa, Ph.D., M.B.A., FACC, FACB (Respondent), who was a Professor,
Chairman, and Executive Vice President of the Pharmaceutical Research
Institute, Albany College of Pharmacy and Health Sciences (ACPHS).
Respondent 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), grant R21
CA135245 and National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), NIH, grant R01 DK052798. The administrative actions,
including supervision for a period of four (4) years, were implemented
beginning on May 15, 2024, 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:
Shaker Mousa, Ph.D., M.B.A., FACC, FACB, Albany College of Pharmacy
and Health Sciences (ACPHS): Based on the report of an investigation
conducted by ACPHS and additional analysis conducted by ORI in its
oversight review, ORI found that Dr. Shaker Mousa (Respondent), former
Professor, Chairman, and Executive Vice President of the Pharmaceutical
Research Institute, ACPHS, engaged in research misconduct in research
supported by PHS funds, specifically NCI, NIH, grant R21 CA135245 and
NIDDK, NIH, grant R01 DK052798. ORI found that Respondent engaged in
research misconduct by intentionally, knowingly, or recklessly
falsifying and/or fabricating chick chorioallantoic membrane (CAM)
assays used to determine angiogenesis activities of small molecules in:
<bullet> Tetraiodothyroacetic acid-conjugated PLGA nanoparticles: a
nanomedicine approach to treat drug-resistant breast cancer.
Nanomedicine (Lond) 2013 Dec;8(12):1943-54. doi: 10.2217/nnm.12.200
(hereafter referred to as ``Nanomedicine (Lond) 2013'').
<bullet> The proangiogenic action of thyroid hormone analogue GC-1
is initiated at an integrin. J. Cardiovasc. Pharmacol. 2005
Sep;46(3):356-60. doi: 10.1097/01.fjc.0000175438.94906.a0 (hereafter
referred to as ``J. Cardiovasc. Pharmacol. 2005''). Retraction in: J.
Cardiovasc. Pharmacol. 2023 Sep 8. doi: 10.1097/FJC.0000000000001471.
Specifically, ORI found that Respondent intentionally, knowingly,
or recklessly falsified and/or fabricated:
<bullet> seven (7) micrograph panels in Nanomedicine (Lond) 2013
and J. Cardiovasc. Pharmacol. 2005 by reusing CAM images from the same
source and falsely relabeling them to report pro-angiogenic factors as
alternate pro-angiogenic factors, anti-angiogenic drug treatments as
alternate anti-angiogenic drug treatments, and control treatments and
anti-angiogenic treatments as the same treatment in:
--FGF2 images in Figure 3A of Nanomedicine (Lond) 2013 and in Figure 2A
of J. Cardiovasc. Pharmacol. 2005 and GC-1 image in Figure 4A of J.
Cardiovasc. Pharmacol. 2005
--FGF2 + T-PLGA-NPs image in Figure 3A in Nanomedicine (Lond) 2013 and
GC-1 + XT199 image in Figure 4A of J. Cardiovasc. Pharmacol. 2005
--FGF2 + tetrac in Figure 3A of Nanomedicine (Lond) 2013 and PBS
Control image in Figure 4A of J. Cardiovasc. Pharmacol. 2005
Respondent entered into a Voluntary Settlement Agreement
(Agreement) and voluntarily agreed to the following:
(1) Respondent will have his research supervised for a period of
four (4) years beginning on May 15, 2024 (the ``Supervision Period'').
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 in PHS-supported
research, Respondent will submit a plan for supervision of Respondent's
duties to ORI for approval. The supervision plan must be designed to
ensure the integrity of Respondent's research. Respondent will not
participate in any PHS-supported research until such a supervision plan
is approved by ORI. Respondent will comply 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 each
application for PHS funds, or report, manuscript, or abstract involving
PHS-supported research in which Respondent is involved. 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, report, manuscript, or abstract
are supported by the research record.
(3) During the Supervision Period, Respondent will ensure that any
institution employing him submits, in conjunction with each application
for
[[Page 47969]]
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 supervision plan is provided to ORI, Respondent will
provide certification to ORI at the conclusion of the Supervision
Period that his participation was not proposed on a research project
for which an application for PHS support was submitted and that he has
not participated in any capacity in PHS-supported research.
(5) During the Supervision 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.
(6) Respondent will request that the following paper be corrected
or retracted:
<bullet> Nanomedicine (Lond) 2013 Dec;8(12):1943-54. doi: 10.2217/
nnm.12.200
Respondent will copy ORI and the Research Integrity Officer at
ACPHS on the correspondence with the journal.
Dated: May 29, 2024.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2024-12167 Filed 6-3-24; 8:45 am]
BILLING CODE 4150-31-P
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