In order to maximize the potential benefit of research using newborn screening residual dried blood samples (DBS), a paradigm shift will be necessary to develop an infrastructure in which parental consent is obtained and the results of genomics research using these samples will be returned to the parents of individual research participants. The goal of this project is to facilitate the development of the normative and legal framework necessary to return results to individual participants in this context.

Genomic data, including findings incidental to the purpose for which a study is undertaken, can contain information of use and importance to research subjects related to their health, lifestyle, and reproductive choices. A growing consensus of expert groups is that at least some information from genomic studies should be available to participants. It seems clear that return of results from genomic studies should and will require the informed consent of research subjects.

The U.S. civil rights movement took place nearly a half century ago, yet significant racial disparities persist in health and justice. The elimination of these disparities is a goal shared by many, including biomedical researchers, medical practitioners, legal scholars, and attorneys. The way in which Americans conceptualize race is more nuanced than the categorical perspective that dominated the early 20th Century. Racial discrimination is itself a health risk factor and known to vary by appearance (e.g. skin pigmentation).

Advances in genomic science are attracting the interest of the U.S. military for their potential to improve medical care for members of the militay and to aid in military recruitment, training and specialization, and mission accomplishment. In addition, large DNA banks operated by the military could be a valuable resource for military and civilian researchers.

Personal genetic and genomic information is becoming more widely available and affordable, generating increased discussions on the merits and dangers of direct-to-consumer (DTC) genetic testing and appropriateness of using personal genetic information in various contexts (e.g. clinics, research laboratories, courtrooms, and classrooms). While attention has focused predominately on health-related testing, conversations about DTC genetic ancestry testing and information are intensifying as well.

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.

The American Society of Human Genetics (ASHG) requests financial support to partially defray speaker and participant travel expenses for an "Ancestry Inference Roundtable" to be held in May, 2012, in Chicago, IL. This meeting will build on an earlier ASHG position statement (ASHG, 2008) and the recommendations of an ASHG ancestry task force, which were published in the American Journal of Human Genetics (Royal et al., 2010).

Personalized medicine (PM) has the potential to transform medicine and the health care system over the next decade. An overlooked variable that will play an important role in the implementation of PM is the potential for legal liability. Physicians, a key gatekeeper in the uptake of PM, are at the greatest risk of liability. Currently, there is great uncertainty, disagreement and rapid change with regard to the use of PM tests in clinical care.

The purpose of this study is to provide empirical data on effects of intellectual property (IP) and commercialization on clinical translation of noninvasive prenatal genetic testing (NIPT) and identify potential barriers to clinical adoption and patient access. Advances in technologies for genetic analysis of cell-free fetal DNA could make NIPT routine. Early clinical trials indicate that sequencing-based NIPT tests for chromosomal aneuploidies are more accurate than currently used noninvasive screening tests.

Genomic information offers the opportunity for "personalized prevention" in both clinical practice and public health settings. To date, such efforts have focused primarily on chronic diseases and their behavioral risk factors. We propose an exploratory CEER to study the ethical, legal, social and policy (ELSP) issues arising in the novel and timely context of infectious disease.