Evolving intellectual property (IP) policies of governments and organizations are impacting biotechnology sectors and access to genetic materials for development of pharmaceuticals. The National Institutes of Health, through the Human Genome Project among others, specifically recognizes the need for policy options in the area of intellectual property to facilitate the widespread use of genetic and genomic information in both research and clinical settings.

The relevance of genomics research for addressing health disparities between population groups is currently being debated. As a practical matter, if genomics hopes to have any role in reducing health disparities, its assumptions and goals will have to make sense to the communities involved. We know very little about what underserved and minority communities that are experiencing health inequities know and think about genomic research and health disparities, and how they might inform research plans if they were invited to discuss it. This project seeks to fill that gap.

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.

A significant number of NIH-funded projects are under the jurisdiction of an explicit data release policy. Such projects include: any project with direct costs of more than $500,00 per year, any genome-wide association study, and most community resource projects.

Biomedical research involving humans generates results that fall on a continuum of potential interest to participants. Some results, such as blood pressure, have obvious clinical utility, and elevated blood pressure is actionable by taking blood pressure medication. At the other end of the continuum, results from research on the genetics of complex diseases holds great promise for future clinical management; however the results are not immediately actionable and may only be of scientific interest.

Obesity rates in the United States have escalated in recent decades and present a growing challenge in public health prevention efforts. Advances in genomics have begun to shed light on the genetic contributions to obesity. At present, it is unknown whether information about one's personal genetic predisposition to obesity will add value to traditional risk communication efforts and increase the likelihood that individuals will engage in health behaviors to reduce obesity risk.

Exome sequencing and whole genome sequencing (ES/WGS) are rapidly emerging as important tools in human genetics research. Unlike conventional approaches, ES/WGS can putatively identify all functional variation in the entire coding sequence of a research participant. As a result, both the number and scope of findings with clinical utility are substantially greater than anticipated by existing guidelines and traditional approaches to return of results.

Recent advances in genomic medicine and genetic testing have increased availability of and access to genetic assessments in both specialty and routine clinical care. Isolation of genetic markers for disease risk among healthy individuals is changing the way in which diseases are detected and defined. Media reports of genetic findings and availability of direct-to-consumer tests may increase both public curiosity and concern.

The objective of this training and research project is to develop the candidate into an independent and interdisciplinary ELSI researcher, with the ability to intertwine qualitative empirical with normative approaches to issues in genetics and genomics.

Innovations in next-generation DNA sequencing technologies, accompanied by exponential drops in cost, have made it possible for clinicians to begin to use whole genome sequencing (WGS) to diagnose, treat, and predict disease. The extent to which WGS will improve health outcomes on a population level, however, will depend on effective oversight of its commercialization and use.