title: Governing population genomics: law, bioethics, and biopolitics in three case studies.
abstract: Existing scholarship on population genomics has only superficially addressed issues of power and political process. Accordingly, questions of politics and governance pervade the analysis of three population genomics case studies that follow: the Human Genome Diversity Project, Iceland's Health Sector Database, and "Clinical Genomics" as defined by the Beth Israel-Ardais collaboration. An examination of these case studies reveals that the common law, U.S. regulatory law, and international law have not developed the political sophistication to make the traditional promises of biomedical ethics--respect for autonomy, justice, and beneficence--come to fruition. Further, comparisons of these projects illuminate three areas ripe for reframing--informed consent, expert ethical oversight, and commercial benefits. Four avenues of reform are suggested.
authors.affiliation: Kennedy School of Government, Harvard University, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Winickoff
mesh_terms: D026683:Advisory Committees; D026686:Beneficence; D001675:Bioethics; D001800:Blood Specimen Collection / Q000941:ethics; D032821:Commodification; D016265:Conflict of Interest; D030561:Databases, Nucleic Acid / Q000941:ethics* / Q000331:legislation & jurisprudence*; D003657:Decision Making; D026724:Ethical Review; D028744:Ethics Committees, Research; D030661:Genetic Privacy; D036281:Genetic Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D005828:Genetics, Population / Q000941:ethics* / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D016045:Human Genome Project; D006806:Human Rights / Q000331:legislation & jurisprudence; D006801:Humans; D007055:Iceland; D007221:Industry; D007258:Informed Consent; D038622:Internationality; D008499:Medical Records; D010330:Patents as Topic; D026684:Personal Autonomy; D011057:Politics; D019724:Presumed Consent; D017149:Private Sector; D017150:Public Sector; D044469:Racial Groups / Q000235:genetics; D035842:Research Subjects; D018570:Risk Assessment; D012935:Social Justice; D014015:Tissue Banks / Q000941:ethics / Q000331:legislation & jurisprudence; D014019:Tissue Donors; D014481:United States