Office of the Secretary April 4, 2007 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that on March 12, 2007 the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of the U.S. Public Health Service (PHS) in the following case: Rebecca Uzelmeier (formerly known as Rebecca Marcus), Michigan State University: Based on the report of an investigation by Michigan State University (MSU) and additional information obtained by the Office of Research Integrity (ORI) during its oversight review, ORI found that Rebecca Uzelmeier, former doctoral student, Department of Pharmacology and Toxicology, MSU, committed misconduct in science by intentionally and knowingly fabricating and falsifying data in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), granted R01 ES02520. ORI issued a charge letter enumerating the above findings of misconduct in science. However, on October 12, 2006, Ms. Uzelmeier filed a request for a hearing under 42 CFR part 93 to dispute these findings before the U.S. Department of Health and Human Services (HHS) Departmental Appeals Board (DAB). On October 19, 2006, ORI moved to dismiss Ms. Uzelmeier's hearing request because it failed to create a genuine dispute of either material fact or law, as required under 42 CFR 93.504. On March 5, 2007, the Administrative Law Judge (ALJ) with the DAB ruled in ORI's favor and dismissed Ms. Uzelmeier's hearing request pursuant to 42 CFR 93.504(a)(2). The ALJ found that Ms. Uzelmeier's hearing request raised defenses that either were immaterial to the charges of misconduct in science or that the ALJ had no authority to grant Ms. Uzelmeier's request for relief under Part 93. Specifically, Ms. Uzelmeier knowingly and intentionally; Fabricated and falsified data in her research notebook primarily by multiple instances of using data/results generated from one experiment to represent data/results purportedly obtained from one or more entirely different experiments; and Fabricated and falsified data in her thesis entitled ``Characterization of the Molecular Mechanism(s) Underlying the Interaction(s) between 2,3,7,8-tetrachlorodibenzo-p-Dioxin Mediated and Interferon Gamma Mediated Signal Transduction,'' including falsifying and fabricating autoradiographic films, computer image files scanned from those films, numerical data reduced from those computer files, documentation of those results in her black three-ring binder, and data in associated multiple figures and projection slides. Ms. Uzlmeier's research concerned the interaction between the environmental toxin, dioxin, and a cytokine, interferon, on cellular signaling in the immune system. The approach was to exploit dioxin, or ``TCDD'' (2,3,7,8-tetrachlorodibenzo-p-dioxin), as a probe that suppresses the immune system to delineate a role for the aryl hydrocarbon receptor protein (AhR), which is a cytosolic receptor that can be transported to the nucleus to also act as a nuclear transcription factor. The specific aim was to determine whether the mechanism of action of a naturally occurring regulatory factor, interferon-[gamma] (IFN-[gamma]), to antagonize the immunosuppressive actions of dioxin, was through reduced AhR signaling. Ms. Uzelmeier's actions caused the withdrawal of a manuscript that had been submitted for publication, the withdrawal of her mentor's PHS grant application, and her dismissal from graduate school. The following administrative actions have been implemented for a period of five (5) years, beginning on March 12, 2007: (1) Ms. Uzelmeier has been debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 2 CFR 180 and 376; and (2) Ms. Uzelmeier is prohibited from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant.