The overall aim of the Center for Genomics and Society (CGS) renewal plan is to carry out an integrated set of transdisciplinary research, training, and policy activities addressing ethical, legal and social Issues involved in the application of genomics to the general public. Genomic testing is already being offered to the general public in an unstudied way by direct-to-consumer companies and through other venues and the use of DNA sequencing to screen populations for preventable health risks is being discussed. But before this potential application of genomics can be realized in the broad population, a number of important ethical, legal, and social concerns will need to be addressed. To create a real-world context in which to study this application of genomics, CGS investigators will design and conduct a trial protocol informed by ELSI perspectives, recruiting 1,000 individuals within a controlled setting, focusing on both highly penetrant rare mutations that place people at risk for eminently preventable conditions and on the assessment of genomic risk for common disease. Unlike other pilot studies aimed at the rapid clinical Implementation of genomics, this interdisciplinary trial is framed to address the key moral questions that the Idea of genomic sequencing for disease prevention raises;what loci and analyses are most appropriate for population-based application? Who within the general population would be the most appropriate users of such a service? How can population genomic sequencing be best Implemented in practice, and with what consequences? Policy recommendations based on the arguments and evidence for and against targeted genomic sequencing in the general population will be formulated, taking into account the harms and benefits, and the personal, clinical, and justice implications. Transdisciplinary research activities will extend CGS collaborations across academic and non-academic communities, and open opportunities for future studies that will extend and complement our research agenda. These research activities have clear, immediate implications for health policy, for professional guidelines, and ultimately for policies that guide genomic research and practice.

Public Health Relevance

This project addresses NIH research priorities related to genomic health care by conducting research to address how evolving genomic technologies can be practically and ethically used in general medical care. The identification of asymptomatic individuals in the population at large who are at high risk for preventable disease represents an important opportunity as genomics is increasingly applied to the general population.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Specialized Center (P50)
Project #
5P50HG004488-07
Application #
8677935
Study Section
Special Emphasis Panel (ZHG1-HGR-P (J1))
Program Officer
Boyer, Joy
Project Start
2007-09-27
Project End
2018-05-31
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
7
Fiscal Year
2014
Total Cost
$1,165,601
Indirect Cost
$397,622
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Adams, Michael C; Evans, James P; Henderson, Gail E et al. (2016) The promise and peril of genomic screening in the general population. Genet Med 18:593-9
Skinner, Debra; Raspberry, Kelly A; King, Martha (2016) The nuanced negative: Meanings of a negative diagnostic result in clinical exome sequencing. Sociol Health Illn 38:1303-1317
Prince, Anya E R (2016) TANTAMOUNT TO FRAUD?: EXPLORING NON-DISCLOSURE OF GENETIC INFORMATION IN LIFE INSURANCE APPLICATIONS AS GROUNDS FOR POLICY RESCISSION. Health Matrix Clevel 26:255-307
Cohn, Elizabeth G; Henderson, Gail E; Appelbaum, Paul S (2016) Distributive justice, diversity, and inclusion in precision medicine: what will success look like? Genet Med :
Cadigan, R Jean; Nelson, Daniel K; Henderson, Gail E et al. (2015) Public Comments on Proposed Regulatory Reforms That Would Impact Biospecimen Research: The Good, the Bad, and the Puzzling. IRB 37:1-10
Prince, Anya E R (2015) Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease. J Law Biosci 2:365-395
Lázaro-Muñoz, Gabriel; Conley, John M; Davis, Arlene M et al. (2015) Response to Open Peer Commentaries on ""Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice"". Am J Bioeth 15:W6-9
Burke, Wylie; Appelbaum, Paul; Dame, Lauren et al. (2015) The translational potential of research on the ethical, legal, and social implications of genomics. Genet Med 17:12-20
Lázaro-Muñoz, Gabriel; Juengst, Eric T (2015) CHALLENGES FOR IMPLEMENTING A PTSD PREVENTIVE GENOMIC SEQUENCING PROGRAM IN THE U.S. MILITARY. Case West Reserve J Int Law 47:87-113
Lázaro-Muñoz, Gabriel; Conley, John M; Davis, Arlene M et al. (2015) Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice. Am J Bioeth 15:3-14

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