Current ethical and legal issues in health-related direct-to-consumer genetic testing
Niemiec, Emilia LU
; Kalokairinou, Louiza
and Howard, Heidi Carmen
LU
(2017)
In Personalized Medicine
14(5).
p.433-445
- Abstract
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... (More)
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.
(Less)
- author
- Niemiec, Emilia
LU
; Kalokairinou, Louiza
and Howard, Heidi Carmen
LU
- publishing date
- 2017-09
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- consumer genetics, consumer genomics, direct-to-consumer genetic testing, genetic counseling, genetic testing, informed consent, IVD Regulation
- in
- Personalized Medicine
- volume
- 14
- issue
- 5
- pages
- 13 pages
- publisher
- Future Science
- external identifiers
-
- pmid:29754566
- scopus:85029917412
- ISSN
- 1741-0541
- DOI
- 10.2217/pme-2017-0029
- language
- English
- LU publication?
- no
- id
- 447d4668-b1f2-4ff2-85cc-f1d01ea5e39f
- date added to LUP
- 2020-11-17 17:25:13
- date last changed
- 2024-03-20 20:29:54
@article{447d4668-b1f2-4ff2-85cc-f1d01ea5e39f,
abstract = {{<p>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.</p>}},
author = {{Niemiec, Emilia and Kalokairinou, Louiza and Howard, Heidi Carmen}},
issn = {{1741-0541}},
keywords = {{consumer genetics; consumer genomics; direct-to-consumer genetic testing; genetic counseling; genetic testing; informed consent; IVD Regulation}},
language = {{eng}},
number = {{5}},
pages = {{433--445}},
publisher = {{Future Science}},
series = {{Personalized Medicine}},
title = {{Current ethical and legal issues in health-related direct-to-consumer genetic testing}},
url = {{http://dx.doi.org/10.2217/pme-2017-0029}},
doi = {{10.2217/pme-2017-0029}},
volume = {{14}},
year = {{2017}},
}