Genome Policy Considerations for Genomic Medicine
This chapter provides an overview of the major policy issues pertaining to research, development, and translation of genomic medicine applications. The issues include research allocation and prioritization, uses and analyses of race in genome studies, ethical issues linked to large-scale genome efforts, privacy and discrimination, and enhancing public and professional awareness. The genetic etiology of common, complex diseases and development of high-throughput technologies at increasingly cheaper costs have enabled the expansion of study populations in genomic studies. Whereas genetic studies traditionally focused on small groups, genomics studies are characterized by the collection of genetic data on hundreds or thousands of individuals. The demand for DNA samples from individuals of various phenotypes has led to the creation of local and national biobanks or biorepositories worldwide. Given the enormity of national biobanks, several policy issues arise, particularly with respect to research policy. The considerations include scientific need and merit, cost and feasibility, required infrastructure, accessibility to samples and data, informed consent, intellectual property (IP), privacy and confidentiality of data, and disclosure of research results to participants. While current policies may be applicable to some of these issues as they are not unique to biobanks, new policies are required to address some of the considerations such as data sharing and data disclosure. © 2010 Copyright © 2010 Elsevier Inc. All rights reserved.
