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

Personalized Medicine
Emilia NiemiecHeidi Carmen Howard

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.

References

Oct 9, 2002·JAMA : the Journal of the American Medical Association·Sarah E GollustBenjamin S Wilfond
Jul 17, 2003·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Sarah E GollustSara Chandros Hull
Jan 14, 2004·European Journal of Human Genetics : EJHG·Béatrice GodardSégolène Aymé
Aug 16, 2008·The Mount Sinai Journal of Medicine, New York·Pascal BorryKris Dierickx
Sep 5, 2008·Annual Review of Genomics and Human Genetics·Stuart HogarthDavid Melzer
Aug 26, 2010·European Journal of Human Genetics : EJHG·UNKNOWN European Society of Human Genetics
Nov 13, 2010·Public Health Genomics·Amy L McGuire, Wylie Burke
May 18, 2011·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Jill S GoldmanUNKNOWN American College of Medical Genetics and the National Society of Genetic Counselors
Nov 24, 2011·Journal of Community Genetics·Heidi Carmen Howard, Pascal Borry
Jan 26, 2012·European Journal of Human Genetics : EJHG·Pascal BorryHeidi Howard
Jun 16, 2012·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Sara L TobinNanibaa' A Garrison
Nov 24, 2012·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Sigrid SterckxPascal Borry
Jan 19, 2013·Science·Melissa GymrekYaniv Erlich
Apr 6, 2013·The American Journal of Bioethics : AJOB·Pascal BorryHeidi Carmen Howard
Sep 24, 2013·Current Genetic Medicine Reports·J Scott Roberts, Jenny Ostergren
Dec 21, 2013·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Dina L G BorzekowskiDebra L Roter
May 9, 2014·Best Practice & Research. Clinical Gastroenterology·Wim Pinxten, Heidi Carmen Howard
Oct 18, 2014·Science·Louiza KalokairinouPascal Borry
Jun 19, 2015·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Shelin Adam, Jan M Friedman
Mar 2, 2016·Annals of Internal Medicine·Wylie Burke, Susan Brown Trinidad
Apr 6, 2016·Applied & Translational Genomics·Emilia Niemiec, Heidi Carmen Howard
Apr 26, 2016·JAMA Pediatrics·Pascal BorryBartha Maria Knoppers
Sep 23, 2016·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Linnea I LaestadiusPaul L Auer
Oct 6, 2016·Journal of Genetic Counseling·Brianne E Kirkpatrick, Misha D Rashkin
Dec 16, 2016·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Adrian ThorogoodBartha Maria Knoppers
Jan 11, 2017·Nature Biotechnology·Jessica L RobertsAmy L McGuire
May 17, 2018·Personalized Medicine·Anna MiddletonHeidi Carmen Howard
Sep 1, 2013·Personalized Medicine·Heather SkirtonAnita O'Connor

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Citations

Jun 7, 2019·Molecular Diagnosis & Therapy·Susanne B Haga
Dec 19, 2018·Frontiers in Genetics·Li Du, Shmuel I Becher
Nov 17, 2020·Annals of Behavioral Medicine : a Publication of the Society of Behavioral Medicine·Susan PerskyBrittany M Hollister
Aug 12, 2021·Biochemistry and Molecular Biology Education : a Bimonthly Publication of the International Union of Biochemistry and Molecular Biology·Alexis N BurianDeborah M Thurtle-Schmidt
Aug 20, 2021·Human Genomics·Nicholas Yan Chai CheungBrian Hon Yin Chung
Sep 3, 2021·American Journal of Medical Genetics. Part B, Neuropsychiatric Genetics : the Official Publication of the International Society of Psychiatric Genetics·Anna DochertyHilary Coon

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Methods Mentioned

BETA
exome sequencing

Software Mentioned

DNA
LiveWello
23andMe
DTC
Graceful
openSNP
ReasearchKit
EQUIP
Counsyl
Genetic Genie

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