Epistemic and ethical considerations in the direct-to-consumer health and ancestry genetic testing process

Background: Direct-to-consumer genetic testing (DTC-GT) is a popular and fast-growing field within the healthcare industry. Consumers often pursue DTC-GT without a clear understanding of its epistemic and medical limitations. This report will present the current state of DTC-GT technology, and highlight the ethical, legal and social issues of DTC-GT. Methods: Quantitative methods such as systematic reviews were used to evaluate the field of DTC-GT. Experimental data was taken from randomized control trials and case studies of 23andMe. Qualitative methods such as newspaper articles and surveys were also used. Relevant policies and regulatory information were analyzed in the context of 23andMe. Broader ethical issues are analyzed from the social disability model and feminist ethics frameworks. Results: Several aspects of direct-to-consumer genetic testing are outlined: (i) regulatory and legal distinctions of DTC-GT that separate its use from conventional genetic testing, (ii) epistemic issues of the genetic testing process within the direct-to-consumer context, and (iii) ethical considerations of DTC-GT in regard to genetic health and genetic ancestry. Conclusion: This report does not take a position for or against the use of DTC-GT; rather, it highlights the key ethical issues often missed in the DTC-GT process. There is no perfect method for understanding genetic health and race. DTC-GT offer consumers the ease and power of taking genetic data ‘in their own hands’, at the cost of exacerbating geneticization and race essentialism. Until further work is done to address the epistemic, regulatory and legal issues, ethical implications of DTC-GT usage will continue to exist.

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Ethical Considerations on Pediatric Genetic Testing Results in Electronic Health Records

Applied Clinical Informatics ◽

10.1055/s-0040-1718753 ◽

2020 ◽

Vol 11 (05) ◽

pp. 755-763

Author(s):

Shibani Kanungo ◽

Jayne Barr ◽

Parker Crutchfield ◽

Casey Fealko ◽

Neelkamal Soares

Keyword(s):

Genetic Testing ◽

Best Practices ◽

Health Care Providers ◽

Genetic Information ◽

Ethical Issues ◽

Interdisciplinary Approach ◽

Care Providers ◽

Ethical Considerations ◽

Electronic Health ◽

Genetic Results

Abstract Background Advances in technology and access to expanded genetic testing have resulted in more children and adolescents receiving genetic testing for diagnostic and prognostic purposes. With increased adoption of the electronic health record (EHR), genetic testing is increasingly resulted in the EHR. However, this leads to challenges in both storage and disclosure of genetic results, particularly when parental results are combined with child genetic results. Privacy and Ethical Considerations Accidental disclosure and erroneous documentation of genetic results can occur due to the nature of their presentation in the EHR and documentation processes by clinicians. Genetic information is both sensitive and identifying, and requires a considered approach to both timing and extent of disclosure to families and access to clinicians. Methods This article uses an interdisciplinary approach to explore ethical issues surrounding privacy, confidentiality of genetic data, and access to genetic results by health care providers and family members, and provides suggestions in a stakeholder format for best practices on this topic for clinicians and informaticians. Suggestions are made for clinicians on documenting and accessing genetic information in the EHR, and on collaborating with genetics specialists and disclosure of genetic results to families. Additional considerations for families including ethics around results of adolescents and special scenarios for blended families and foster minors are also provided. Finally, administrators and informaticians are provided best practices on both institutional processes and EHR architecture, including security and access control, with emphasis on the minimum necessary paradigm and parent/patient engagement and control of the use and disclosure of data. Conclusion The authors hope that these best practices energize specialty societies to craft practice guidelines on genetic information management in the EHR with interdisciplinary input that addresses all stakeholder needs.

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Genetic Testing for Minors: Comparison between Italian and British Guidelines

Genetics Research International ◽

10.1155/2012/786930 ◽

2012 ◽

Vol 2012 ◽

pp. 1-4 ◽

Cited By ~ 4

Author(s):

Pamela Tozzo ◽

Luciana Caenazzo ◽

Daniele Rodriguez

Keyword(s):

Clinical Practice ◽

Genetic Testing ◽

Ethical Issues ◽

Social Issues ◽

Carrier Testing ◽

European Countries ◽

National Guidelines ◽

Common Framework ◽

Professional Guidelines

Genetic testing in children raises many important ethical, legal, and social issues. One of the main concerns is the ethically inappropriate genetic testing of minors. Various European countries established professional guidelines which reflect the different countries perspectives regarding the main ethical issues involved. In this paper, we analyze the Italian and the British guidelines by highlighting differences and similarities. We discuss presymptomatic, predictive, and carrier testing because we consider them to be the more ethically problematic types of genetic testing in minors. In our opinion, national guidelines should take into account the different needs in clinical practice. At the same time, in the case of genetic testing the national and supranational protection of minors could be strengthened by approving guidelines based on a common framework of principles and values. We suggest that the Oviedo Convention could represent an example of such a common framework or, at least, it could lead to articulate it.

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“I would rather have it done by a doctor”—laypeople’s perceptions of direct-to-consumer genetic testing (DTC GT) and its ethical implications

Medicine Health Care and Philosophy ◽

10.1007/s11019-018-9837-y ◽

2018 ◽

Vol 22 (1) ◽

pp. 31-40 ◽

Cited By ~ 9

Author(s):

Manuel Schaper ◽

Sabine Wöhlke ◽

Silke Schicktanz

Keyword(s):

Genetic Testing ◽

Ethical Implications ◽

Direct To Consumer

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Ethical Considerations in the Genetic Testing Laboratory

10.1093/med/9780190604929.003.0013 ◽

2017 ◽

Author(s):

Daniel Groepper ◽

Matt Bower

Keyword(s):

Genetic Testing ◽

Ethical Issues ◽

Conflicts Of Interest ◽

Ethical Dilemmas ◽

Prenatal Testing ◽

Laboratory Setting ◽

Test Results ◽

Ethical Considerations ◽

Testing Laboratory ◽

Testing Laboratories

Ethical dilemmas are commonly encountered by genetic counselors, whether in the clinical or laboratory setting. This chapter describes common ethical dilemmas, conflicts, and challenges encountered in genetic testing laboratories. These situations include genetic testing of minors for adult-onset conditions, prenatal testing, the ethical impacts of incidental findings and unexpected test results, and conflicts of interest. This chapter also explores the genetic counselor’s role in addressing ethical issues. Resources are provided for managing these ethical dilemmas within the laboratory.

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Ethical Language and Themes in News Coverage of Genetic Testing

Journalism & Mass Communication Quarterly ◽

10.1177/107769900007700112 ◽

2000 ◽

Vol 77 (1) ◽

pp. 160-174 ◽

Cited By ~ 16

Author(s):

David A. Craig

Keyword(s):

Genetic Testing ◽

Ethical Theory ◽

Ethical Issues ◽

News Coverage ◽

Ethical Implications ◽

News Organizations

Ethical theory is employed in this study to assess news coverage of genetic testing, a topic with widely acknowledged ethical implications for professions and society. Ethical language and themes were examined in thirty-one broadcast and print stories by major news organizations in 1995 and 1996. Concerns about consequences, especially avoidance of harm, were prominent in most stories; ethical duties received less attention. Ethical themes, sometimes emerging as direct questions to readers or viewers, underlined choices facing individuals and society. Some stories powerfully brought home ethical issues without directly mentioning ethics.

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A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264620920460 ◽

2020 ◽

Vol 15 (4) ◽

pp. 355-364

Author(s):

Rebekah McWhirter ◽

Lisa Eckstein ◽

Don Chalmers ◽

Christine Critchley ◽

Jane Nielsen ◽

...

Keyword(s):

Data Sharing ◽

Ethical Issues ◽

Social Issues ◽

Genomic Data ◽

Community Members ◽

Direct To Consumer ◽

Public Sharing ◽

Key Issues ◽

Consumer Test ◽

Legal And Ethical Issues

Sharing of genomic and associated data is essential to clinical practice and biomedical research, and is increasingly encouraged by journals and funding bodies. Grappling with the range of legal and ethical issues raised by genomic data sharing presents a significant challenge, given the diversity of practices: from defined sharing of individual patient data, to broad-scale public sharing of research data, to uploading of direct-to-consumer test data by community members. Most commentary to date has discussed these issues in broad terms, but the debate can only progress if we engage with more granularity, grounded in jurisdictional and contextual specifics. We developed an empirical approach, creating a set of prototypical scenarios that capture the diversity of current genomic data sharing practices, which allows legal and ethical analysis of key issues at a granular level. The specificity of this approach provides a strong foundation for developing useful and relevant regulatory recommendations.

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Empowerment or exposure? Ethical dilemmas of visual methods with vulnerable migrants

Qualitative Research Journal ◽

10.1108/qrj-10-2019-0075 ◽

2020 ◽

Vol 20 (3) ◽

pp. 329-340

Author(s):

Melissa Hauber-Özer ◽

Meagan Call-Cummings

Keyword(s):

Ethical Issues ◽

Visual Methods ◽

Participatory Methods ◽

Ethical Guidelines ◽

Ethical Considerations ◽

Content Type ◽

Migrant Populations ◽

Methodological Choices ◽

Ethical Implications ◽

Participatory Inquiry

PurposeThe purpose of this paper is to present a typology of the treatment of ethical issues in recent studies using visual participatory methods with immigrants and refugees and provide insights for researchers into how these issues can be more adequately addressed.Design/methodology/approachThe paper presents the results of a scoping study as a typology of ethical considerations, from standard IRB approval to complete ethical guidelines/frameworks for research with refugee/migrant populations.FindingsThe review reveals that there is a broad spectrum of ethical considerations in the use of visual participatory methods with migrants, with the majority only giving cursory or minimal attention to the particular vulnerabilities of these populations.Originality/valueThis paper encourages university-based researchers conducting participatory inquiry with migrant populations to engage in deeper critical reflection on the ethical implications of these methods in keeping with PAR's ethico-onto-epistemological roots, to make intentional methodological choices that are congruent with those roots and to be explicit in their description of how they did this as they disseminate their work.

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‘Sham Surgery’ Control Groups: Ethics and Context

Research Ethics ◽

10.1177/174701611100700405 ◽

2011 ◽

Vol 7 (4) ◽

pp. 148-155 ◽

Cited By ~ 1

Author(s):

Teresa Swift

Keyword(s):

Patient Autonomy ◽

Ethical Issues ◽

Best Interests ◽

Surgical Research ◽

Ethical Considerations ◽

Control Groups ◽

Ethical Implications ◽

Sham Surgery ◽

Surgical Trial ◽

Ethical Acceptability

The use of placebo controls in surgical research, or ‘sham surgery’ as it sometimes described, raises a number of ethical issues. Despite such issues, sham surgery is presently being employed, albeit very rarely, in surgical research. In this paper, the ethical implications of such control groups are discussed in the context of research into various conditions, including Parkinson's Disease and arthritis. Conflicting ethical considerations include: i) patients' best interests in relation to the harms and risks involved; ii) the need for more rigorous methods in surgical research, and iii) the question of patient autonomy. Contextual features which may influence the ethical acceptability of a specific sham-controlled surgical trial are discussed.

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O-060 Ethical implications of the direct to consumer genetic testing. What should donors and recipients know?

Human Reproduction ◽

10.1093/humrep/deab127.040 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

L Frith

Keyword(s):

Genetic Testing ◽

Extended Family ◽

New Era ◽

Online Systems ◽

Donor Conception ◽

Ethical Implications ◽

Direct To Consumer ◽

Regulatory Systems ◽

The Many ◽

The Uk

Abstract Abstract text The growth in the use of direct-to-consumer-genetic testing (DTCGT) is having a major impact on sperm, egg and embryo donor conception (hereafter donor conception). DTCGT services include family history sites, e.g. Ancestry.com, and medical testing sites, e.g.23andme. Despite the many different motivations people have for using these services, it is now easier to search and find donor relatives, with donor-conceived people, recipients of donor gametes and embryos, and donors all using these services to make hitherto unlikely connections. Some individuals have found large numbers of donor-siblings, while donors have been traced by their adult donor offspring. DTCGT can also reveal unexpected origins with the numbers of people finding out they are donor-conceived through DTCGT rapidly increasing. For example, one woman discovered she was donor conceived after using 23andme to assess her risk of breast cancer, an eventuality she had never anticipated when she decided to take that test. The increasing use of DTCGT has led to claims that donor anonymity is dead and we are entering a new era where the possibilities of finding our genetic relatives and extended family have dramatically expanded. These developments will produce new landscapes where different systems collide and interact, creating new ways of locating and finding donor relatives. In the UK for example, information on genetic relations, donors and donor siblings, is located within two very different systems: ‘official’ regulatory systems, such as central registers of information held by government bodies such as the Human Fertilisation and Embryology Authority’s (HFEA) registers; and emerging digital online systems, of DTCGT. This paper will explore how these new developments interact with existing ways of finding out information about donor relatives and consider the ethical and legal issues and challenges for fertility practice.

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