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Case Summary: Mousa, Shaker

Shaker Mousa, Ph.D., M.B.A., FACC, FACB, Albany College of Pharmacy and Health Sciences: Based on the report of an investigation conducted by Albany College of Pharmacy and Health Sciences (ACPHS) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, ORI found that Shaker Mousa, Ph.D., M.B.A., FACC, FACB (Respondent), who was a Professor, Chairman, and Executive Vice President of the Pharmaceutical Research Institute, ACPHS, 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.

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:
     
    1. 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.
       
    2. 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 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. 


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Source URL: https://ori.hhs.gov/content/case-summary-mousa-shaker