PROJECT NARRATIVE ?Precision medicine? and other advances in genetic research require access to massive amounts of genetic and related health data, but private genetic datasets are growing rapidly in both value and size and pose a challenge to the public genetic data market. This research proposes to characterize and evaluate the factors influencing these genetic data partnerships (beginning with academics), compare market drivers to current existing governance structures, and offer a model for best practices.

Project Narrative The potential benefits and harms of returning genomic results to children and their parents are matters of enduring controversy?especially genomic results for adult-onset conditions that are not medically actionable in childhood. Empirical data to support either position in this controversy are, however, lacking.

PROJECT NARRATIVE Human genome editing is a powerful tool for creating precise changes to the genome, the complete set of genetic material. However, human genome editing raises significant ethical, legal, and social challenges, and making policy that can better anticipate and prepare for these challenges is urgently needed. This project will be the first comprehensive empirical study to apply strategies of anticipatory governance to the management and control of human genome editing technologies.

PROJECT NARRATIVE The University of Utah Center for Excellence in ELSI research explores issues relevant to population testing and screening for genetic conditions in the healthcare of women and children, as well as ELSI issues arising from testing and screening in the broader family context and responses to disabilities identified through genetic technologies. The Center supports cores in research, education and career advancement, and administration.

PROJECT NARRATIVE The ability to recruit and protect research participants across multiple sites and multiple states is critical to the success of large-scale precision medicine and other biomedical research supported by the National Institutes of Health and other federal agencies to improve human health. Accomplishing this task requires a clear understanding of which state?s laws apply and under what circumstances, but the empirical and normative foundations for addressing choice of law questions in a research context are lacking.

The goal of ELSI.hub, a National Center for ELSI Resources and Analysis, is to serve as a locus for resource sharing and community building to enhance the production, sharing, and use of research on the ethical, legal, and social implications of genetics and genomics (ELSI research).

PROJECT NARRATIVE The sickle cell trait (SCT) screening program of the National Collegiate Athletic Association (NCAA) is regarded as one of the largest mandated genetic screening programs in the United States (US). Estimates suggest that over 2,000 NCAA Division I student-athletes with SCT will be identified under the screening policy and that, without intervention, about seven NCAA Division I student-athletes would die suddenly from a complication of SCT over a 10-year period.

PROJECT NARRATIVE Little is known about how health care providers (HCPs) will react to, and use, genomic information in patient care. The goal of this study is to understand how genomic information impacts HCPs and to make recommendations that will enhance HCPs' ability to successful integrate this information into clinical medicine.

Project Narrative Currently, there are marked differences in variant classification among clinical laboratories, and genetic variant classification is currently in flux with improvements in the access to ethnically diverse reference data and new algorithms to predict the pathogenicity of variants. As variants are re-classified over time, there is currently no definitive guidance from professional organizations about how to handle this variant reclassification and who has the duty to re-classify variants and what those obligations are.

Project Narrative This project will identify and reduce ethical and practical barriers to sharing qualitative research data. It will develop new resources to increase data sharing in an ethical manner, which will improve the quality of research data, facilitate new research in a cost-effective manner, and foster the training of new researchers.