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  • Zafgen’s Beloranib IND gets complete clinical hold after second death

    • 12.10.2015

    Zafgen, a Boston-based biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has received verbal notice from the FDA that its beloranib investigational new drug (IND) application has been placed on complete clinical hold, affecting the ongoing open label extension (OLE) portion of the pivotal […]

  • Misconduct Found in 11 Papers Published Over Nine-Year Period

    • 12.10.2015

      Girija Dasmahapatra, a former instructor in the Department of Medicine at Virginia Commonwealth University (VCU), committed research misconduct in 11 papers published from 2005 to 2014. Dasmahapatra “falsified and/or fabricated data by reporting the results of Western blot experiments and mouse imaging experiments that examined interactions between multiple histone deacetylase and/or proteasome inhibitors in […]

  • ORI Case Summary – Potti, Anil

    • 11.16.2015

    Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Anil Potti, M.D., Duke University School of Medicine:  Based on the reports of investigations conducted by Duke University School of Medicine (Duke) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. […]

  • Cancer Research Doctor Sentenced For Theft

    • 10.19.2015

    PHILADELPHIA – Steven W. Johnson, Ph.D., 50, of Elkins Park, PA, was sentenced today to 12 months and one day in prison for theft from a program receiving federal funds.  Johnson pleaded guilty on April 30, 2015 to one count of misusing federal funds for cancer research to conduct a for-profit business.  In addition to […]

  • FDA Warning Letter

    • 09.29.2015

    Failure to submit and obtain FDA approval of an IDE application, and failure to ensure that an Institutional Review Board was promptly informed of significant new information about an investigation. A sponsor is responsible for submitting an IDE application for an investigation of a significant risk device to the FDA, and shall not begin an investigation […]

  • HHS Announces In the Federal Register: Proposal to Improve Rules Protecting Human Research Subjects

    • 09.22.2015

    The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies announced proposed revisions to modernize, strengthen and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf. To be assured consideration, comments must be […]

  • Debarment of Two Investigators

    • 12.16.2014

    The HHS Office of Research Integrity (ORI) recently announced the debarment of two investigators who are prohibited from receiving government funding and serving in advisory capacities for three-year periods. Igor Dzhura, a former senior research associate in the Department of Biomedical Engineering at Vanderbilt University, “engaged in research misconduct by providing falsified and/or fabricated data […]

  • Postdoctoral Fellow Engaged in Misconduct

    • 12.15.2014

    ORI also found that Kaushik Deb, a former postdoctoral fellow at the University of Missouri-Columbia, engaged in misconduct in connection with a paper that was retracted in 2007, a year after it was published. ORI said Deb “intentionally, knowingly, and recklessly fabricated and falsified data” in a paper, “Cdx2 gene expression and trophectoderm lineage specification […]

  • ORI Case Summary – Falsified survival times of mice

    • 08.29.2014

    Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Jun Fu, Ph.D., University of Texas MD Anderson Cancer Center: Based on the Respondent’s admission, the report of an inquiry conducted by the University of Texas MD Anderson Cancer Center (MDACC), and analysis conducted by ORI in […]

  • ORI Case Summary – Falsified data in publications

    • 07.29.2014

    Case Summary: Zou, Zhihua DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct AGENCY:  Office of the Secretary, HHS. ACTION:  Notice. SUMMARY:  Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Zhihua Zou, Ph.D., Harvard Medical School and Fred Hutchinson […]