The current landscape for direct-to-consumer genetic testing: Legal, ethical, and policy issues

被引:174
|
作者
Hogarth, Stuart [1 ]
Javitt, Gail [2 ]
Melzer, David [3 ]
机构
[1] Univ Loughborough, Dept Social Sci, Loughborough LE11 3TU, Leics, England
[2] Johns Hopkins Univ, Genet & Publ Policy Ctr, Washington, DC 20036 USA
[3] Peninsula Med Sch, Epidemiol & Publ Hlth Grp, Exeter EX2 5DW, Devon, England
基金
英国惠康基金;
关键词
personalized genomics; government regulation; DNA profiling;
D O I
10.1146/annurev.genom.9.081307.164319
中图分类号
Q3 [遗传学];
学科分类号
071007 ; 090102 ;
摘要
This review surveys the developing market for direct-to-consumer (DTC) genetic tests and examines the range of companies and tests available, the regulatory landscape, the concerns raised about DTC testing, and the calls for enhanced oversight. We provide a comparative overview of the situation, particularly in the United States and Europe, by exploring the regulatory frameworks for medical devices and clinical laboratories. We also discuss a variety of other mechanisms such as general controls on advertising and consumer law mechanisms.
引用
收藏
页码:161 / 182
页数:22
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