The Ethical, Legal and Social Implications (ELSI) Programs of the National Institutes of Health and Department of Energy were established to address ethical and related issues raised by the Human Genome Project. A stated goal of the ELSI program has been to influence policy related to the ethical, legal and social issues raised by advances in genetics. While there have been several attempts to measure the degree to which the ELSI program has achieved this goal, there has not been a systematic assessment of ELSI's impact on policy.

This proposal requests funding to support an evaluation of existing regulatory frameworks and their appropriateness for the regulation of new probiotic products that are available in the market or will be available in the near future.

It is recognized that research on the human microbiome is important for its potential scientific and medical impact. The complexity of microbiome research, however, could change the way that genetics is studied and understood because it calls for a more complex, nuanced framework for defining and demonstrating causality. The understanding of the human microbiome could also disrupt traditional assumptions about definitions of species, self, disease and normality. It is also recognized that microbiome research can raise ethical, legal, and social issues.

The overall purpose of this grant is to explore the nature, extent and consequences of data-sharing and data- withholding in academic genetics and the other life sciences.

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.

The purpose of the Newborn Sequencing In Genomic medicine and public HealTh (NSIGHT) program is to explore, in a limited but deliberate manner, the implications, challenges and opportunities associated with the possible use of genomic sequence information in the newborn period. Funds will be used to stimulate research in three component projects specifically applicable to newborn screening:

1) Acquisition and analysis of genomic datasets that expand considerably the scale of data available for analysis in the newborn period.

Human genome editing is a powerful tool for creating precise changes to the genome, an organism+D6s complete set of genetic material. With these advances has come an explosion of interest in the possible applications of genome editing, both in conducting basic research and the potential to prevent, treat, and cure disease and disability. Genome editing could provide insights into reproductive failures and improve contraception and fertility treatments.