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Short List of Candidates for the EPA Human Studies Review Board

On March 5, 2010, the EPA, Office of the Science Advisor (OSA) announced a request for nominations of qualified individuals in the areas of bioethics, biostatistics, human health risk assessment and human toxicology to serve on the EPA Human Studies Review Board (HSRB) (Federal Register 75 43, 91235). Information on the HSRB, including the nomination process, appears in the above-referenced Federal Register notice and on the HSRB Web site.

The OSA has reviewed the nominations and identified 6 possible candidates to serve on the HSRB. Brief biographical sketches ("biosketches") on these candidates are provided below. OSA invites comments or other documentation from members of the public that the OSA should consider in the selection of HSRB members. Any information furnished by the public in response to this Web site posting will be combined with information already provided by the candidates, and gathered independently by the OSA. Prior to final selection of HSRB members, the combined information will be reviewed and evaluated for any possible financial conflict of interest or a possible appearance of a lack of impartiality. The information will also be used to ensure appropriate balance and breadth of expertise needed to address the charge to the Board. Candidates not selected for membership might be considered in the future as vacancies become available, used as a consultant to the HSRB or as a member or consultant to an HSRB subcommittee. Please e-mail your comments no later than noon, Eastern Time, April 16, 2010 to Jim Downing, OSA (downing.jim@epa.gov).

HSRB Nominees:

Virginia Ashby Sharpe, Ph.D.

Dr. Sharpe is an ethicist on the staff of the Veterans Health Administration (VHA), National Center for Ethics in Health Care and a visiting scholar at Georgetown University where she teaches courses in environmental ethics and clinical ethics.
At VHA, Dr. Sharpe supports policy development and implementation on a broad range of ethical issues including adverse event disclosure, conflicts of interest and professionalism, release of protected health information, and organ donation. She also directs the VHA Pandemic Influenza Ethics Initiative, developing ethical guidance and resources for pandemic flu planning and response. Since 1998, Dr. Sharpe has been an advisory board member to the Mothers and Newborns study at the Columbia Center for Children's Environmental Health. This community-based cohort study uses biomarker research and environmental monitoring to study the effects of several common pollutants on children's health in Harlem and Washington Heights.

Dr. Sharpe received her Ph.D. with honors in philosophy from Georgetown University and her A.B. with honors from Smith College. Prior to her work at VHA, she was the director of the Integrity in Science project at the Center for Science in the Public Interest (CSPI). Her work at CSPI involved education and advocacy to address conflicts of interest in scientific research and federal and state science-based policy. Dr. Sharpe was also Deputy Director and an Associate for Biomedical and Environmental Ethics at the Hastings Center, a bioethics education institute in Garrison, NY.

Dr. Sharpe has spoken widely and published numerous books and articles on ethical issues concerning health care and the environment, including Accountability: Patient Safety and Policy Reform. (Georgetown University Press, 2004); "Knowledge, Norms and the Politics of Risk: Ethical Issues in Policy-Relevant Science." In David Bellinger, ed. Human Developmental Neurotoxicology. (New York: Marcel Dekker, 2006): 511-525; "What are We Doing When We're Doing Research on Humans?" Neurotoxicology and Teratology 2002:24(4):451-4.Wolves and Human Communities: Biology, Politics, and Ethics. (Island Press, 2001); and Medical Harm: Historical, Conceptual and Ethical Dimensions of Iatrogenic Illness. (Cambridge U. Press, 1998)

George Fernandez, Ph.D.

George Fernandez is a professor of applied statistical methods and serves as the director for the University of Nevada – Reno Center for Research Design and analysis. His publication records include, applied statistics books, a CD-Rom, 60 journal papers, and more than 30 conference proceedings.

George Fernandez, has more than 23 years of experience in teaching applied statistics courses and SAS programming. His Teaching experience includes APST 755 (Applied multivariate statistical methods), APST 463/663 (Design and analysis of experiments), APST 705 (Regression and correlations), APST 458/658 (Introduction to SAS programming), and APST 270 (Introduction to statistical analysis). Dr. Fernandez has served in more than 60 MS thesis 30 PhD dissertation committees. Experienced IACUC committee member and CITI certified IRB approved researcher. His book on "Data mining using SAS applications" (CRC press / Chapman Hall) contains many user-friendly SAS macro-applications. Many international and national SAS users are currently using his user-friendly SAS applications. He won several best paper and poster presentation awards at the regional and international conferences. He has presented invited full-day workshops on "Applications of user-friendly statistical methods in Data mining. He devised a user-friendly screening chart to detect childhood obesity and invented a simple formula to estimate body’s maximum weight limit. Based on these findings he received national and international recognition. He organized several sections on Data Mining and predictive Modeling and Statistics sections in SAS Global Forum Conference (2009-2006) Inc, Quintiles Inc, and USDA-ARS (April 2004). He served as the Academic Program Reviewer- Food and Resource Economics program, University of Delaware May 2007.

He served as Associate Editor/Statistics: American Society for Horticultural sciences Journal, HortScience. (1999-2007), and American Potato Research Journal (2003-present). Presented Invited 2-day courses on Statistical data mining using SAS macro applications. Organized by the CDC Atlanta and presented at National Center for Health Statistics, Maryland (M&TU) and at the National Institute for Occupational Hazard study Morgan Town WV (TH&F) June 2004.

Elizabeth Heitman, Ph.D.

Dr. Heitman is an Associate Professor Medical Ethics, with appointments in the Division of General Medicine in the Department of Medicine and the Department of Anesthesiology’s Division of Critical Care. She also holds an appointment in the Department of Religious Studies in the College of Arts and Science. She received her Ph.D. in Religious Studies from Rice University.

Dr. Heitman’s research addresses the evaluation of education in research ethics and the responsible conduct of research (RCR), and the cultural awareness and professional socialization of students and researchers. Dr. Heitman is the Director of a four-year, research ethics education program for Costa Rican biomedical researchers and research ethics review committees, in conjunction with the Hospital Nacional de Ninos in San Jose, Costa Rica, and sponsored by the NIH’s Fogarty International Center. She is also principal investigator for a National Science Foundation-sponsored study of international science graduate students´ experience of US standards of practice in ethical research. She is a member of the Education Core of the Vanderbilt Institute of Clinical and Translational Research (VICTR) and provides research ethics consultation as a member of VICTR’s Biostatistics/Ethics Core. Her research collaborations include the Policy, Ethics, and Law Core of the South East Regional Center for Excellence in Biodefense and Emerging Infections and the NCRR -sponsored URICA study of institutional climate for ethical research. She is also a consultant to the NHLBI-sponsored Jackson Heart Study Undergraduate Training Program at Tougaloo College in Jackson, Mississippi.

At Vanderbilt, Dr. Heitman is Co-Chair of the Ethics Committee and a member of the Critical Care Committee and Organ Donation Advisory Committee. In the Medical School, Dr. Heitman teaches ethics, responsible conduct of research, and community health, as well as advising students in the Humanities Area, Community Health, and Global Health areas of the Emphasis Program. As a member of the Center for Medicine, Health and Society and Department of Religious Studies in the College of Arts and Science she teaches ethics in public health, responsible conduct of research, and advises a variety of independent study projects for undergraduates.

Jose Manautou, Ph.D.

Jose Manautou is Associate Professor of Toxicology and the Marlene L. Cohen and Jerome H. Fleisch Scholar in the Department of Pharmaceutical Sciences at the School of Pharmacy of the University of Connecticut.

Dr. Manautou has been an active member of the Society of Toxicology (SOT) since he joined as a student member. In 2003, he was elected Councilor of the SOT and has also served in key committees and task forces for the society. He has served as member of the National Research Council Committee Assessing the Human Health Risks of Trichloroethylene and is currently Associate Editor for the journal Toxicology and Applied Pharmacology. He is also on the editorial board of four other journals.
Dr. Manautou was the recipient of the 2006 SOT Achievement Award and the 2008 AstraZeneca Traveling Lectureship Award. He recently completed a 4-year term as member of the National Institutes of Health Xenobiotic and Nutrient Disposition and Action (XNDA) Study Section and has also served as an external reviewer of grants for the European Commission.

Dr. Manautou received his B.S. in Pharmacy from the University of Puerto Rico, Ph.D. in Pharmacology and Toxicology from Purdue University and postdoctoral training in biochemical toxicology at the University of Connecticut. He also conducted sabbatical research at the Amsterdam Liver Center of the University of Amsterdam, The Netherlands.

Jason Richardson, M.S., Ph.D.

Jason Richardson, M.S., Ph.D. is an Assistant Professor at in the Department of Environmental and Occupational Medicine at Robert Wood Johnson Medical School and Resident Member of the Environmental and Occupational Health Sciences Institute (EOHSI). He received his M.S. and Ph.D. degrees from Mississippi State University where he conducted research on mixtures of organophosphate pesticides and the developmental neurotoxicity of organophosphates during critical periods of development. He then completed postdoctoral training in Molecular Neuroscience and Neurotoxicology at Emory University where he focused on the role of pesticide exposure in Parkinson’s disease. His research at EOHSI focuses on the role of environmental exposures during development and how such exposures interact with genetic susceptibility to produce neurological disease. Dr. Richardson has authored or co-authored 30 publications in the areas of developmental neurotoxicology, neurodegenerative disease, and pesticides. He has received the Outstanding New Environmental Scientist Award from the National Institute of Environmental Health Sciences and a Young Scientist Award from the American Society for Pharmacology and Experimental Therapeutics. Dr. Richardson is currently a member of the editorial boards of Toxicological Sciences and Neurotoxicology, and is an Associate Editor for BMC Neurology. He has served as a grant reviewer for several NIH panels, the Michael J. Fox Foundation for Parkinson’s Disease Research, Autism Speaks, and the United Kingdom Parkinson’s Disease Society.

Dr. Richardson’s research focus is Mechanisms of Neurological Disease and Dysfunction. His Ph.D. is in Environmental Toxicology and he has a Master of Science degree in Veterinary Medical Science/Toxicology from Mississippi State University.

David Umbach, Ph.D.

Dr. Umbach is a Staff Scientist in the Biostatistics Branch of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health. He is a member of the Biometrics Society, the Institute of Mathematical Statistics, and the American Statistical Association. Last year, he was elected a Fellow of the American Statistical Association for outstanding work as a statistical consultant in environmental health research and for substantive contributions to statistical methods in epidemiology and statistical genetics.

Dr. Umbach has published over 80 peer-reviewed scientific papers. His primary research interest is the development of new statistical tools for detecting and characterizing gene-environment interactions through epidemiologic studies. He also actively collaborates with NIEHS researchers on laboratory and epidemiologic studies that investigate, for example, environmental and genetic influences on neurodegenerative diseases such as Parkinson’s disease and amyotrophic lateral sclerosis, effects of pesticides on respiratory diseases in the Agricultural Health Study cohort, and the hormonal effects of soy formula in infants. His research is funded through the Intramural Research Program of the NIH.

Dr. Umbach has served as Member of the Expert Panel for Review of Soy Formula and Genistein, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction (2005-2006). He has held elective offices within the Statistics and Environment Section of the American Statistical Association and has served as associate editor of the Journal of the American Statistical Association (1996-1999). He is currently serving on a Data Safety Monitoring Board for a multicenter trial.

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