Are the kids really all right? Direct-to-consumer genetic testing in children: are company policies clashing with professional norms?

Howard, Heidi; Avard, Denise; Borry, Pascal

doi:10.1038/ejhg.2011.94

Cited by 37 publications

(29 citation statements)

References 21 publications

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“…Three companies would consider testing if it was requested by a minor. 51 Finally, there is no consistency regarding the information provided on DTC GT websites regarding consent for testing. Information on DTC GT websites might not be balanced with regard to how they present risks and benefits.…”

Section: Direct-to-consumer Testingmentioning

confidence: 99%

Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

Botkin

Belmont

Berg

et al. 2015

The American Journal of Human Genetics

464

338

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In 1995, the American Society of Human Genetics (ASHG) and American College of Medical Genetics and Genomics (ACMG) jointly published a statement on genetic testing in children and adolescents. In the past 20 years, much has changed in the field of genetics, including the development of powerful new technologies, new data from genetic research on children and adolescents, and substantial clinical experience. This statement represents current opinion by the ASHG on the ethical, legal, and social issues concerning genetic testing in children. These recommendations are relevant to families, clinicians, and investigators. After a brief review of the 1995 statement and major changes in genetic technologies in recent years, this statement offers points to consider on a broad range of test technologies and their applications in clinical medicine and research. Recommendations are also made for record and communication issues in this domain and for professional education.

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Section: Direct-to-consumer Testingmentioning

confidence: 99%

Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

Botkin

Belmont

Berg

et al. 2015

The American Journal of Human Genetics

464

338

View full text Add to dashboard Cite

show abstract

“…Although pharmacogenetics was not discussed in the ESHG statement, there are potential problems for inclusion in DTC services 19 if, for example, the consumer is then tempted to adjust their dose of prescribed medicine without seeking medical advice. Testing of samples from minors (including carrier testing) and third parties (who have not consented) should not be permitted but there is evidence that some DTC services are including genetic testing in minors, 20 contradicting established professional guidelines, including those of the ESHG.…”

Section: The Scope Of Dtc Genetic Testingmentioning

confidence: 99%

The perspective from EASAC and FEAM on direct-to-consumer genetic testing for health-related purposes

Fears

Boccia

Cornel³

et al. 2012

Eur J Hum Genet

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Direct-to-consumer (DTC) genetic testing services raise scientific, regulatory and ethical questions. A report was prepared by consultation with an expert Working Group and published by the academies of science (European Academies of Science Advisory Council, EASAC) and medicine (Federation of European Academies of Medicine, FEAM). This report reviews current scientific evidence, ascertains the principles that should underpin the options for action by policy-makers, and discusses the potential for devising proportionate and flexible regulation that enables future innovation, taking account of the work of other expert groups, most notably the European Society of Human Genetics. EASAC-FEAM concluded that DTC genetic testing has little clinical value at present, and expresses especial caution in several specific respects, for example relating to testing for high penetrance, serious disorders, prenatal screening, nutrigenomic and pharmacogenetic testing. It was emphasised that regulation must be on the basis that claims about the link between genetic marker and disease are scientifically valid. Other key issues to address include quality assurance (that includes the professional interpretation of results), transparent supply of accurate information, consideration of the implications for established health services, and clarification of consent procedures for any use of data for research purposes. There are important implications: for the European Commission, in revising the Directive on In Vitro Diagnostic Medical Devices; for professional bodies, in supporting training and guideline development; for the broader research community, in generating the evidence base; and for the public health community, in improving the routine translation of research advances into clinical practice

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“…[5][6][7][8][9] First, informed consent may be compromised by lack of provision of appropriate facts. 9 Second, confidentiality may be breached through integration of online social networking opportunities into the websites of DTC-GT companies which promote sharing of personal genomic information 7 and, although this may facilitate collaboration between clients and researchers, the consequences of these potential confidentiality breaches are difficult to predict.…”

Section: Introductionmentioning

confidence: 99%

“…8 Third, although most DTC-GT companies maintain that their services are not intended to attract minors, testing in minors continues to occur. 5,6 Although there is a body of literature regarding DTC-GT, observational studies are limited. Some case studies have reported DTC-GT results with apparent clinical utility [10][11][12] and other studies report results with no clinical utility.…”

Section: Introductionmentioning

confidence: 99%

An exploration of genetic health professionals' experience with direct-to-consumer genetic testing in their clinical practice

et al. 2012

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Direct-to-consumer genetic testing (DTC-GT) allows individuals to obtain genetic tests directly from companies without necessarily involving health professionals. This study explores genetic health professionals' opinions of health-related DTC-GT and the reported frequency of individuals presenting to clinical genetics services after undertaking testing. Genetic counsellors and clinical geneticists, members of the Human Genetics Society of Australasia, completed an online survey in mid 2011. The 130 genetic counsellors (estimated response fraction¼43%) and 38 clinical geneticists (estimated response fraction¼46%) had mixed opinions regarding DTC-GT, with only 7% confident in accurately interpreting and explaining DTC-GT results. Nineteen respondents (11%) reported one or more client(s) referred to them after undertaking DTC-GT. Descriptions of 25 clients were extracted from responses, and respondents reported that all clients were concerned for the health of either themselves or family members. Most clients presented to genetic clinics specifically as a result of their DTC-GT (96%) and were self or GP referred (92%). Respondents perceived that their clients typically undertook DTC-GT because they wanted to identify monogenic conditions, including carrier testing and/or know their susceptibility or predisposition for complex conditions (88%). The majority of clients needed help interpreting DTC-GT results (80%), however in general were not questioning the validity of their DTC-GT results (92%) nor seeking further genetic testing (84%). Currently, DTC-GT is not a major reason for referral to clinical genetics services in Australia and New Zealand and the majority of genetic health professionals lack confidence in being able to accurately interpret and explain DTC-GT results. European Journal of Human Genetics (2012) 20, 825-830; doi:10.1038/ejhg.2012.13; published online 8 February 2012Keywords: direct-to-consumer; health professional; genetic testing; genetic counsellor; attitudes INTRODUCTIONMany direct-to-consumer genetic tests (DTC-GT) have unknown clinical validity and utility, 1-3 and their use to assess disease risk is therefore controversial. In addition, the personalised genetic risk information provided by DTC-GT may be interpreted solely by consumers without guidance from appropriate health professionals. For example, in a recent longitudinal cohort study to measure the effects of DTC-GT, only 10.4% of subjects reported discussing their results with one of the genetic counsellors provided by the testing company. 4 Un-informed interpretation of genetic test results may inappropriately heighten health-related anxiety or apathy and subsequently lead to poor life choices; however, this has not been proven. There is also potential for other psychological effects on consumers due to lack of knowledge and support. The long-term demands on health services and impact on health behaviour as a result of DTC-GT are yet to be established.Various publications have identified a number of other issues with ethical, leg...

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Are the kids really all right? Direct-to-consumer genetic testing in children: are company policies clashing with professional norms?

Cited by 37 publications

References 21 publications

Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

The perspective from EASAC and FEAM on direct-to-consumer genetic testing for health-related purposes

An exploration of genetic health professionals' experience with direct-to-consumer genetic testing in their clinical practice

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