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.

Research on the genetics of Psychiatric, Neurologic, and Behavioral (PNB) phenotypes reveals a panorama of complexity that creates several challenges: 1) the data are difficult for clinicians to assimilate and integrate into their practices, and even more so for patients and other members of society to understand and use; 2) because the traits investigated by PNB geneticists often have significance for our self-perceptions, new data can challenge our self-images in fundamental ways.

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.

Assignment of individuals to categories of race, ethnicity and ancestry impacts health and public policy, yet the practice remains both scientifically and culturally controversial. The established means of determining race and ethnicity, as commonly used for census and health questionnaires, is self-identification. However data is accumulating from social science research showing that an individual's reported ancestry is dependent on social and cultural context. At the same time, modern genetic studies have identified robust markers of ancestry.

This project employs a multi-method, transdisciplinary approach that combines ethnographic participant- observation, interview research methods, ethical, legal, and public policy analyses. The two goals of the present project are 1) to identify the ethical, legal, and policy challenges that the field of psychiatric genomics will face when trying to translate the findings of large-scale GWAS into clinically useful information, and 2) to make evidence-based recommendations about how to address these challenges.

Prenatal testing is evolving in two important ways: first, advances in genomic medicine mean that samples of fetal DNA obtained with invasive methods (such as amniocentesis) can be analyzed using microarray analysis or whole genome sequencing, revealing far more information about the fetus's genetic make-up than was previously possible; and second, new, non-invasive prenatal tests have been introduced that isolate fragments of fetal DNA circulating in a pregnant woman's blood, making possible safe, highly accurate genetic testing much earlier in pregnancy than was previously possi

Advances in psychiatric genetics are likely to offer major diagnostic and therapeutic benefits, but also legal and social-related risks, to individuals who were diagnosed with, or have a proclivity for, psychiatric disorders. In response, courts and policy-makers will have to ensure that psychiatric genetic data are used to promote, and not to obstruct, equality, justice, and social inclusion.

This project employs multiple methods and a transdisciplinary approach to explore policy options for US federal and state governments seeking to address how life, long-term care, and disability insurers use genetic information. The analysis will focus on legal standards of actuarial justification, that is, the requirement that insurers m+R409ust show a statistical correlation between a risk factor and increased cost in order to use that factor in an underwriting decision such as a policy denial or an increased premium.

Concerns about privacy and personal identity impede use of data about genomic variation, phenotypes, demographics, and exposures from large numbers of people to uncover the contributions of such information on health and disease, knowledge that can improve clinical care. People worry that these data and genomic data in particular, cannot be secured. Many fear that data about them will be used in ways they oppose (e.g., to deny them and those they love access to jobs and insurance) because existing legal rules about such uses are not comprehensive.

Addictive disorders are increasingly conceptualized as biomedical diseases with genetic roots. While conventional wisdom has suggested that attributing addictions to genetics should have many benefits, there is reason to suspect that it could have some unintended, negative consequences. In particular, genetic explanations for addictive disorders could lead to the perception that people with addictions lack agency or self-efficacy to overcome their symptoms and to the belief that non-biomedical treatments, such as psychotherapy, are unlikely to be effective.