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Current ethical and legal issues in health-related direct-to-consumer genetic testing

Niemiec, Emilia, Dr (author)
Univ Bologna, Interdept Ctr Res Hist Philosophy & Sociol Law &, I-40121 Bologna, Italy.; Univ Turin, Dept Law, I-10153 Turin, Italy.; Leibniz Univ Hannover, Ctr Eth & Law Life Sci, Inst Philosophy, D-30159 Hannover, Germany
Kalokairinou, Louiza (author)
Katholieke Univ Leuven, Ctr Biomed Eth & Law, Dept Publ Hlth & Primary Care, B-3000 Leuven, Belgium
Howard, Heidi Carmen (author)
Uppsala universitet,Centrum för forsknings- och bioetik
Univ Bologna, Interdept Ctr Res Hist Philosophy & Sociol Law &, I-40121 Bologna, Italy; Univ Turin, Dept Law, I-10153 Turin, Italy.; Leibniz Univ Hannover, Ctr Eth & Law Life Sci, Inst Philosophy, D-30159 Hannover, Germany Katholieke Univ Leuven, Ctr Biomed Eth & Law, Dept Publ Hlth & Primary Care, B-3000 Leuven, Belgium (creator_code:org_t)
Future Medicine Ltd, 2017
2017
English.
In: Personalized Medicine. - : Future Medicine Ltd. - 1741-0541 .- 1744-828X. ; 14:5, s. 433-445
  • Research review (peer-reviewed)
Abstract Subject headings
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  • A variety of health-related genetic testing is currently advertized directly to consumers. This article provides a timely overview of direct-to-consumer genetic testing (DTC GT) and salient ethical issues, as well as an analysis of the impact of the recently adopted regulation on in vitro diagnostic medical devices on DTC GT. DTC GT companies currently employ new testing approaches, report on a wide spectrum of conditions and target new groups of consumers. Such activities raise ethical issues including the questionable analytic and clinical validity of tests, the adequacy of informed consent, potentially misleading advertizing, testing in children, research uses and commercialization of genomic data. The recently adopted regulation on in vitro diagnostic medical devices may limit the offers of predisposition DTC GT in the EU market.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)

Keyword

Bioetik
Bioethics

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