Department of Health and Human Services June 28, 2012 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Mona Thiruchelvam, Ph.D., University of Medicine and Dentistry of New Jersey: Based on the report of an investigation conducted by the University of Medicine and Dentistry of New Jersey (UMDNJ) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Mona Thiruchelvam, former Assistant Professor, Department of Environment and Occupational Health Science Institute (EOHSI), UMDNJ, engaged in research misconduct in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grants P30 ES05022, P30 ES01247, and R01 ES10791 and the intramural program at the National Institute on Drug Abuse (NIDA), NIH. ORI found that the Respondent engaged in research misconduct by falsifying and fabricating cell count data that she claimed to have obtained through stereological methods in order to falsely report the effects of combined exposure of the pesticides paraquat and maneb on dopaminergic neuronal death and a neuroprotective role for estrogen in a murine model of Parkinson's disease. The Respondent provided to the institution corrupted data files as the data for stereological cell counts of nigrostriatal neurons in brains of several mice and rats by copying a single data file from a previous experiment and renaming the copies to fit the description of 13 new experiments composed of 293 data files when stereological data collection was never performed for the questioned research. The fabricated data, falsified methodology, and false claims based on fabricated and falsified data were reported in two NIEHS, NIH, grant applications, two publications, a poster, and a manuscript in preparation: R01 ES016277, ``Development Pesticide Exposure: The Parkinson's Disease Phenotype'' (Dr. Mona J. Thiruchelvam, Principal Investigator [P.I.]), submitted 1/26/2007 and funded. R01 ES015041, ``Gender and the Parkinson's Disease Phenotype'' (Dr. Mona J. Thiruchelvam, P.I.), submitted 12/19/05. Rodriguez, V.M., Thiruchelvam, M., & Cory-Slechta, D.A. ``Sustained Exposure to the Widely Used Herbicide, Atrazine: Altered Function and Loss of Neurons in Brain Monamine Systems.'' Environ Health Perspect. 113(6):708-715, 2005 (``EHP paper''). Thiruchelvam, M., Prokopenko, O., Cory-Slechta, D.A., Richfield, E.K., Buckley, B., & Mirochnitchenko, O. ``Overexpression of Superoxide Dismutase or Glutathione Peroxidase Protects against the Paraquat + Maneb-induced Parkinson Disease Phenotype.'' J. Biol. Chem. 280(23):22530-22539, 2005 (``JBC paper''). Harvey, K., Victor, A.I., Wang, Y., Kochar, Y., Cory- Slechta, D.A., & Thiruchelvam, M. ``Gene Delivery of GDNF Impedes Progressive Neurodegeneration in Paraquat and Maneb Exposure Model of Parkinson's Disease.'' Poster presentation, Neuroscience 2006 (``Neuroscience poster''). Thiruchelvam, M., Kochar, Y., Mehta, H., Prokopenko, O., Cory-Slechta, D.A., Richfield, E.K., & Mirochnitchenko, O. ``Mechanisms associated with gender difference in the paraquat and maneb animal model of Parkinson's disease, 2006 (``manuscript''). Specifically, ORI finds that the Respondent engaged in research misconduct by knowingly and intentionally: Falsifying and fabricating summary bar graphs and methodology for stereological cell counts in a murine model of Parkinson's disease, when the stereological counts were never performed; Copying and altering in multiple ways a single stereology ``.dat'' computer file generated on August 18, 2002, and renaming it to generate 293 data files representing counts for 13 new experiments that were never performed, by altering the files to make them unreadable and claiming that these files were from valid stereological cell count experiments carried out at UMDNJ between 2004 and 2006; Falsifying a bar graph representing brain proteasomal activity, by selectively altering data for relative fluorescent unit (RFU) values to support the hypothesis that development of Parkinson's disease entails proteasomal dysfunction with a higher effect in males compared to females; By failing to perform stereological cell counts, the following figures of summary bar graphs, reported methodology, and related claims of the Respondent's JBC paper, EHP paper, a manuscript, a poster, and two grant applications were falsified:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.