Individual DNA samples and health information sold by 23andMe

Adam, Shelin; Friedman, Jan M.

doi:10.1038/gim.2015.82

Cited by 8 publications

(6 citation statements)

References 10 publications

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“…Interestingly, the company 23andMe not only uses consumers' data for research, but has also sold access to consumers' data affected with Parkinson to a biotech company Genentech for research purposes [60]. Selling access to consumers' data seems to raise similar concerns to those outlined by Sterckx et al (2014) when discussing patenting activities of 23andMe.…”

Section: Research Uses and Commercialisation Of Consumers' Genetic Inmentioning

confidence: 79%

“…Consequently, the company may own the largest research databank in the world consisting of genetic information of consented re-contactable subjects. 4 The compliance of these research activities with research ethics requirements, in particular the adequacy of informed consent for participation in research and data privacy, has been questioned [57,58,60,61]. Similar issues were raised in recent studies of DTC GT websites (one of which investigated companies offering WES/WGS) exploring issues such as secondary uses of samples and data, data confidentiality and privacy.…”

Section: Research Uses and Commercialisation Of Consumers' Genetic Inmentioning

confidence: 93%

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

2017

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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 declare no conflict of interest. 2 AbstractA variety of health-related genetic testing is currently advertised 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 (IVD) on DTC GT. DTC GT companies currently employ new testing approaches, report on 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 advertising, testing in children, research uses and commercialization of genomic data. The recently adopted IVD Regulation may limit the offers of predisposition DTC GT in the EU market.Keywords: direct-to-consumer genetic testing, genetic testing, consumer genomics, consumer genetics, informed consent, genetic counselling, IVD regulation 1 Many of the tests discussed herein involve generating the DNA sequence for much if not all of the genome, therefore it could be considered more accurate to use the term genomic. However, for the purposes of this article, we will be using the word 'genetic' referring both to genetic and genomic testing and services. DTC genetic testing and related services2 This article focuses mainly on health-related testing, excluding testing with other main purposes such as ancestry and paternity. However, it is important to note that ancestry test results may reveal health-related information to consumers, given associations between genetic ancestry and disease risks, press coverage of these relations and interest of the consumers in these issues [85]. Furthermore, the web-based interpretation services can provide health-related information on the basic of raw data received in ancestry genetic testing, which is discussed in the following sections of this article. (2015) revealed that the market of health-related DTC GT has grown significantly in the last decade reaching over 100 companies [6]. Considering that these searchers were performed in English, the total number of companies offering DTC GT may be assumed to be even larger.Importantly, not only has the number of companies grown in recent years, but their offer has expanded regarding the scope of the tests, technologies used, and the target audiences of the tests. (almost) all the DNA present in cells, whilst whole exome sequencing provides sequence of all protein coding regions of DNA; in both cases the amount of genetic information obtained is unprecedented. Once sequenced, the exome or genome can then be analysed for specific, defined purpose(s) (e.g. using targeted gene approach where only a subset of genes ...

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Section: Research Uses and Commercialisation Of Consumers' Genetic Inmentioning

confidence: 79%

Section: Research Uses and Commercialisation Of Consumers' Genetic Inmentioning

confidence: 93%

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

2017

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“…Some of the ethical concerns regarding the research practices of DTC WGS companies discussed herein have been raised previously ( Gibson and Copenhaver, 2010 , Howard et al, 2015 ). Furthermore, earlier this year, it was reported that the DTC GT company 23andMe together with the biotechnology company Genentech was to perform WGS on 23andMe consumers' samples, raising concerns about informed consent, data privacy, management of incidental findings and availability of the data to other researchers ( Adam and Friedman, 2015 ). Although the ethical and legal study of DTC GT companies has been ongoing for almost a decade, it would appear that some of the ethical concerns about these companies and their research activities have not been resolved, but rather amplified as new sequencing technologies are implemented.…”

Section: Discussionmentioning

confidence: 99%

Ethical issues in consumer genome sequencing: Use of consumers' samples and data

Niemiec

Howard

2016

Applied & Translational Genomics

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High throughput approaches such as whole genome sequencing (WGS) and whole exome sequencing (WES) create an unprecedented amount of data providing powerful resources for clinical care and research. Recently, WGS and WES services have been made available by commercial direct-to-consumer (DTC) companies. The DTC offer of genetic testing (GT) has already brought attention to potentially problematic issues such as the adequacy of consumers' informed consent and transparency of companies' research activities. In this study, we analysed the websites of four DTC GT companies offering WGS and/or WES with regard to their policies governing storage and future use of consumers' data and samples. The results are discussed in relation to recommendations and guiding principles such as the “Statement of the European Society of Human Genetics on DTC GT for health-related purposes” (2010) and the “Framework for responsible sharing of genomic and health-related data” (Global Alliance for Genomics and Health, 2014). The analysis reveals that some companies may store and use consumers' samples or sequencing data for unspecified research and share the data with third parties. Moreover, the companies do not provide sufficient or clear information to consumers about this, which can undermine the validity of the consent process. Furthermore, while all companies state that they provide privacy safeguards for data and mention the limitations of these, information about the possibility of re-identification is lacking. Finally, although the companies that may conduct research do include information regarding proprietary claims and commercialisation of the results, it is not clear whether consumers are aware of the consequences of these policies. These results indicate that DTC GT companies still need to improve the transparency regarding handling of consumers' samples and data, including having an explicit and clear consent process for research activities.

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“…[31] Similar contextual concerns were raised when 23andMe partnered with GlaxoSmithKline and also sold access to their database of Parkinson's affected users to Genetech, but with far less public traction. [8] Despite 23andMe not being an actual medical practitioner, the participants' primary association of DTCGT was health-related. Combined with the triviality of providing the sample itself (saliva), this context normalized the process of providing one's DNA to a DTCGT company.…”

Section: The Impact Of Contextmentioning

confidence: 99%

“…However, the company encourages participation with these features, and notes in the help pages that they will not permanently delete your genetic information due to legal obligations, a fact that is only obliquely disclosed in their privacy policy. 8 This creates a "Roach 158:26…”

Section: Implications For Designmentioning

confidence: 99%

"Becoming Part of Something Bigger"

King

2019

Proc. ACM Hum.-Comput. Interact.

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Direct to consumer genetic testing (DTCGT) services where users can identify their inherited diseases and traits, find genetic relatives, and learn more about their ethnic heritage continue to grow in popularity. At the same time, one's DNA is one of the most identifiable, immutable forms of personal information, and sharing it carries risks to one's privacy. What motivates individuals to engage in DTCGT, and what are the implications for information privacy at both the individual and societal levels? This study uses qualitative interviews with ten customers of the DTCGT service 23andMe to explore why they engaged in DTCGT, the benefits they received, their expectations of privacy, and perceptions of risk. It also introduces the use of social exchange theory as a theoretical framework for examining the social dimensions of information privacy and personal disclosure. The findings demonstrate that the participants' assumptions of anonymity, as well as their their belief that their contributions to online genetic databases aid the public good, were key motivating factors. The participants were generally unaware of the potential risks to their individual genetic privacy as well as the impact of large scale genetic testing databases on networked, collective privacy. The findings demonstrate that framework of social exchange theory aids in understanding how the form of the relationship affected the participants' decisions to disclose their personal information to 23andMe as well as their perceptions of risk in the DTCGT context. CCS Concepts: • Human-centered computing → Empirical studies in HCI; Empirical studies in collaborative and social computing; • Security and privacy → Social aspects of security and privacy;

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Individual DNA samples and health information sold by 23andMe

Cited by 8 publications

References 10 publications

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

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

Ethical issues in consumer genome sequencing: Use of consumers' samples and data

"Becoming Part of Something Bigger"

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