We propose an exploratory survey, parallel to the Human Microbiome Project (HMP), of the emergent ethical, legal, and social issues associated with human microbiome research. We will implement this study using in- depth interviews with key stakeholders in the HMP, including individuals who are recruited to the HMP but decline participation, study participants, and investigators and project leaders involved in planning for an conducting the first phases of the HMP.

Rapid advancements in genetic technology, the popularity and coverage of genetics by the press, and the increased understanding of the role genetics plays in our health necessitates a basic understanding of the science for everyone. In spite of this increased exposure to genetics, a study by Bowling (2008) indicated that the public's genetics literacy remains relatively low. Studies looking specifically at the genetics knowledge of students in grades K-12 also show low levels of understanding.

One of the intended goals of the ELSI CEER program is to provide guidance on policy issues that arise from novel genetic and genomic science and applications. This focus, however, misses epigenetic processes. Epigenetics involves the point at which nature and nurture intersect via discrete environmentally imposed modifications to the genome. These modifications include DNA methylation, and their distribution across the genome creates cell-specific epigenomes that control cell-specific expression patterns.

Biobanks that collect and store participants' clinical and genetic information have become important tools in genomic research, disseminating data to a large number of investigators conducting genome-wide association studies and other genomic research. The ubiquity of these biobanks in research and the fact that many of their uses will be undetermined at the time a participant consents pose a host of ethical challenges related to privacy rights, participant consent, and data sharing.

This qualitative study is designed to examine the ethical conduct of clinical research, including the conduct of clinical trials, in rural healthcare settings. This study is of great significance since more than half of the clinical research, including pharmacogenomic studies, conducted in the U.S. takes place in physicians' offices, clinics, and hospitals.(1-8) It is no longer unusual to encounter rural physicians, nurses, research coordinators, and hospital administrators who are engaged, in various capacities, in the clinical research enterprise.

This research project will collect and analyze qualitative and quantitative data about US biobanks, exploring how organizational strategies, features, and attributes affect both framing and response to ELSI and policy choices. We argue that a biobank's organizational features impact 1) policy choices directly, and 2) members' framing and response to ELSI which in turn impact policy choices.

The objective of this project is to address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and bloodspot sample retention specifically. This project has the following specific aims: Specific Aim 1) To determine what pregnant women, young mothers, and their partners want to know regarding the retention and use of residual bloodspot samples ' Methods include 15 focus groups conducted in five states (NY, CA, UT, MN, WA).

The long-term goal of this research is to develop multimedia technology and interactive instructional strategies to improve the effectiveness and efficiency of obtaining informed consent for human DNA and tissue biorepositories. Studies suggest that individuals do not sufficiently understand the information presented during biorepository consent processes, and that traditional consent processes pose resource challenges for large-scale biorepositories.

Harvesting the benefits of genomics requires a new kind of transdisciplinary cooperation. Over the next three years, we will create the Center for Transdisciplinary ELSI Research in Translational Genomics (CT2G) to address key ELSI questions in translational research. The proposed Center brings together the unique resources of Kaiser Permanente Northern California (KPNC), including its Division of Research, and the University of California, San Francisco (UCSF), including the Hastings College of the Law Consortium on Law, Science & Health Policy.

This application proposes the establishment of a Center for Research on the Ethical, Legal and Social Implications of Psychiatric, Neurologic and Behavioral (PNB) Genetics at Columbia University Medical Center (CUMC). Since April 2010, we have been funded under a P20 Developing Center grant to create the infrastructure and begin development of such a Center.