Current ethical and legal issues in health-related direct-to-consumer genetic testing
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Current ethical and legal issues in health-related direct-to-consumer genetic testing. / Niemiec, Emilia; Kalokairinou, Louiza; Howard, Heidi Carmen.
In: Personalized Medicine, Vol. 14, No. 5, 09.2017, p. 433-445.Research output: Contribution to journal › Review › Research › peer-review
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TY - JOUR
T1 - Current ethical and legal issues in health-related direct-to-consumer genetic testing
AU - Niemiec, Emilia
AU - Kalokairinou, Louiza
AU - Howard, Heidi Carmen
N1 - Publisher Copyright: © 2017 Future Medicine Ltd.
PY - 2017/9
Y1 - 2017/9
N2 - 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.
AB - 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.
KW - consumer genetics
KW - consumer genomics
KW - direct-to-consumer genetic testing
KW - genetic counseling
KW - genetic testing
KW - informed consent
KW - IVD Regulation
UR - http://www.scopus.com/inward/record.url?scp=85029917412&partnerID=8YFLogxK
U2 - 10.2217/pme-2017-0029
DO - 10.2217/pme-2017-0029
M3 - Review
C2 - 29754566
AN - SCOPUS:85029917412
VL - 14
SP - 433
EP - 445
JO - Personalized Medicine
JF - Personalized Medicine
SN - 1741-0541
IS - 5
ER -
ID: 369542712