Using emerging genomic information to create opportunities for targeted or risk-based screening in cancer prevention and control is a critical component of President Obama's Precision Medicine Initiative. But precision genomic screening raises multiple ELSI (ethical, legal, social, and policy) concerns. The proposed embedded ELSI research project presents a unique opportunity to follow and assess the ELSI issues that accompany a pioneering randomized pragmatic clinical trial of a risk-based approach to breast cancer screening.

The overall goal of this proposed project is to systematically develop culturally appropriate model ethics guidelines for conducting genetics and genomics research (GGR) in Uganda.

Project Summary The breakneck pace of development towards potential uses of germline gene editing (GGE) in medicine raises some very crucial ethical questions. Though much research still needs to be done before GGE will be safe for use on humans, the technology has progressed very rapidly over the past few years. Among the most pressing of the ethical issues raised by GGE are those concerning human subjects research. Future clinical trials will confront novel ethical conundrums that are difficult to resolve given current guidelines.

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. Returning results for adult-onset conditions can spur life-saving preventive measures in the parents of affected children. However, there has been long-standing concern that children who receive a result for an adult-onset condition might experience negative psychosocial outcomes such as distress or altered family functioning.

From the passage of the country's first sterilization law in Indiana in 1907 until the 1960s approximately 60,000 people were sterilized based on eugenic criteria that sought to regulate the reproduction of the "unfit" and mentally deficient. California performed about 20,000, or one-third, of all documented sterilizations nationwide. Few empirical historical analyses of this practice are available. In 2007, while conducting historical research at the Department of Mental Health (now Department of State Hospitals) in Sacramento, Dr.

The state of knowledge regarding the human microbiome is advancing rapidly and a burgeoning new area of research and development is microbiome-based diagnostics. There is much that is not yet known about the implications of microbiome-based diagnostic or screening test results and it is possible that existing laws and regulations that did not contemplate these technological advancements are not adequate to address legal, regulatory, ethical and social concerns they raise.

This K99/R00 Award is designed to generate scholarship and interventions to guide genomics companies towards more just practices. It does so through a five-year training and research project, which investigates perspectives from members of the genomics industry, and leverages them to inform normative analyses and identify feasible paths towards concrete change. The project addresses issues of price, access and industrial control, with a focus on the ethics of profit and social responsibility.

Recent expansions in prenatal genetic testing have renewed concerns from both disability advocates and right- to-life movements that these tests serve primarily to enable elective terminations, However, as prenatal genetic testing becomes easier, safer, and more accessible, many women say they choose it for a very different reason: preparation.

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 Preparation is often cited as a reason for offering and for accepting prenatal genetic screening and diagnosis. However, this term has no clear definition, and thus it is impossible either to prove benefit or to recommend best practices.