The project is relevant to public health because it will explore the risks and benefits of nontraditional biological experimentation, which is currently conducted largely beyond the reach of external regulation, and consider what regulatory approach would best serve the public interest.
Project Narrative. This K99/R00 Pathway to Independence Award will prepare the candidate to become an independent, mixed-methods ELSI researcher pursing a research program on ethical issues related to the actionability of genomic information. The study examines the values and assumptions underlying conceptualizations of the actionability of genomic information for healthy populations. Results of the study will contribute to the ethical and effective implementation of genomic sequencing into care for healthy populations.
Project Narrative. Advances in psychiatric, neurologic and behavioral (PNB) genetics have brought the prospect of predictive and diagnostic genomic testing for many PNB conditions closer to clinical application. The potential for such findings to profoundly affect core elements of personhood?including identity, perceived responsibilities, and life trajectories?makes it essential to understand the impact of such information on individuals and families.
This Pathway to Independence Award (K99/R00) investigates and leverages perspectives from members of the health-related private sector genomics industry, to develop guidance for improving approaches to social and ethical issues in the industry. It does so through in-depth qualitative analysis (interviews, cases studies, comparative analysis), scholarly normative analysis (drawing on theories from bioethics and business ethics), and a Delphi process of iterative questionnaires with industry stakeholders, aimed at strategizing concrete change regarding social obligations of the industry.
The proposal is a longitudinal study of potential neurobiological and neurobehavioral markers of disease onset and progression in pre-symptomatic individuals who have the CAG expansion in the HD gene. A total of 500 subjects will be enrolled. Study subjects will be 30 to 55 years old and have a parental history of Huntington's disease. The study will enroll 425 cases with >39 CAG repeats (affected), and 75 controls with . . . (supplement)
Accompanying the increase in research activities worldwide, particularly in developing countries where the citizens are poor, vulnerable and un-empowered, is increasing concern about the ethical nature of these studies, the rights of participants, the need to protect vulnerable populations, issues relating to benefitssharing, equity and justice. It has therefore become necessary to equip researchers, particularly in developing countries with state-of-the-art knowledge of research ethics.
Duke's Center for the Study of Public Genomics will gather and analyze information about the role of publication, data sharing, materials-sharing, patenting, database protection, and other practices that affect information flow in genomics research and development. Managing intellectual property and ensuring the preservation of a robust "scientific commons" could prove as difficult as or more so than the science and technology, and could have as large of an impact on what results are produced, who has access to them, and how fairly they are distributed.
Modern genetic research gives us unprecedented ability to understand and manipulate fundamental biological processes. Our growing potential to understand and shape the world in genetic terms also seriously challenges basic beliefs and ethical norms. At the same time, values and norms affect the way genetic research is designed and conducted. Despite the significant ethical and societal implications of emerging genetic research, there are few venues for geneticists to participate in interdisciplinary research and to discuss these issues.
Genomic research is rapidly expanding our knowledge about the genetic contributors to health and disease. A broad range of health benefits will flow from this research, including tests to predict disease risk and guide drug use, innovative therapies, and improved understanding of the interactions between genetic and environmental contributors to health. However, the specific benefits will vary for different diseases and populations, influenced by the nature of the genetic and non-genetic contributors, and the availability and safety of therapeutic options.
The Center for Integration of Research on Genetics and Ethics (CIRGE) was established in 2004. The overall goal of CIRGE is the proactive identification and integration of ethical, legal and social considerations into the design and conduct of current and emerging genetic research. Our thematic focus is on genomics of behavioral traits.