Professor Maxwell Mehlman was named the Principal Investigator on a $710,000 grant from NIH. The National Human Genome Research Institute at the NIH has been instrumental in developing the ethical, legal, and policy framework essential for conducting PGM research and translating the results into clinical practice. But to date, there has been no significant attempt to determine how the design, conduct, interpretation, and dissemination of CER research on PGM should be shaped by the lessons that have been learned. This R01 project will respond to this gap by comprehensively examining the specific ethical, legal, and social issues raised by comparative effectiveness research on personalized genomic medicine and proposing a set of points to consider in designing, conducting, interpreting, and disseminating this research so that it can be carried out in an ethical, legal, and socially appropriate manner. The project will be conducted over two years. In addition to Mehlman, the investigators are Georgia Wiesner, Associate Professor of Genetics and Medicine at Case Western Reserve University and the director of the Center for Human Genetics at University Hospitals of Cleveland, Mendel Singer, Associate Professor of Epidemiology and Biostatistics at the Case Western Reserve University School of Medicine, and Shawneequa Callier, Assistant Professor, Department of Clinical Research and Leadership, School of Medicine and Health Sciences, The George Washington University.

Professor Maxwell Mehlman was named the Principal Investigator on a $710,000 grant from NIH. The National Human Genome Research Institute at the NIH has been instrumental in developing the ethical, legal, and policy framework essential for conducting PGM research and translating the results into clinical practice. But to date, there has been no significant attempt to determine how the design, conduct, interpretation, and dissemination of CER research on PGM should be shaped by the lessons that have been learned. This R01 project will respond to this gap by comprehensively examining the specific ethical, legal, and social issues raised by comparative effectiveness research on personalized genomic medicine and proposing a set of points to consider in designing, conducting, interpreting, and disseminating this research so that it can be carried out in an ethical, legal, and socially appropriate manner. The project will be conducted over two years. In addition to Mehlman, the investigators are Georgia Wiesner, Associate Professor of Genetics and Medicine at Case Western Reserve University and the director of the Center for Human Genetics at University Hospitals of Cleveland, Mendel Singer, Associate Professor of Epidemiology and Biostatistics at the Case Western Reserve University School of Medicine, and Shawneequa Callier, Assistant Professor, Department of Clinical Research and Leadership, School of Medicine and Health Sciences, The George Washington University.