January 25, 2016

New FOA for Research on Research Integrity (Phase I)

The purpose of this Funding Opportunity Announcement (FOA) is to foster innovative approaches to empirical research on societal, organizational, group, and individual factors that affect, both positively and negatively, integrity in research. Integrity is defined as the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results with particular…

December 10, 2015

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

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

  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…

November 16, 2015

ORI Case Summary – Potti, Anil

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….

October 19, 2015

Cancer Research Doctor Sentenced For Theft

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…

September 29, 2015

FDA Warning Letter

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…

September 22, 2015

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

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…

December 16, 2014

Debarment of Two Investigators

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…

December 15, 2014

Postdoctoral Fellow Engaged in Misconduct

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…

August 29, 2014

ORI Case Summary – Falsified survival times of mice

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…

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