[Federal Register Volume 89, Number 108 (Tuesday, June 4, 2024)]
[Notices]
[Pages 47968-47969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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'').
     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:
     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:

 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