Current Ethical and Legal Issues in Health-Related Direct-To-Consumer Genetic Testing

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 in vitro diagnostic medical devices may limit the offers of predisposition DTC GT in the EU market.

Keywords::

• consumer genetics
• consumer genomics
• direct-to-consumer genetic testing
• genetic counseling
• genetic testing
• informed consent
• IVD Regulation

Financial & competing interests disclosure

E Niemiec is supported by Erasmus Mundus Joint International Doctoral Program in Law, Science and Technology Fellowship. HC Howard is supported by the Swedish Foundation for Humanities and Social Sciences (Riksbankens Jubileumsfond under grant M13–0260:1), the Biobanking and Molecular Resource Infrastructure of Sweden (BBMRI.se), and the BBMRI-ERIC. This work is also supported by the COST Action IS1303 ‘Citizen’s Health through public-private Initiatives: Public health, Market and Ethical perspectives’ (CHIP ME). None of these funding sources have had any involvement in the preparation of this article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

E Niemiec is supported by Erasmus Mundus Joint International Doctoral Program in Law, Science and Technology Fellowship. HC Howard is supported by the Swedish Foundation for Humanities and Social Sciences (Riksbankens Jubileumsfond under grant M13–0260:1), the Biobanking and Molecular Resource Infrastructure of Sweden (BBMRI.se), and the BBMRI-ERIC. This work is also supported by the COST Action IS1303 ‘Citizen’s Health through public-private Initiatives: Public health, Market and Ethical perspectives’ (CHIP ME). None of these funding sources have had any involvement in the preparation of this article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.