Abstract
The declining cost of DNA sequencing has been accompanied by a proliferation of companies selling ‘direct-to-consumer genetic testing’ (DTC-GT) services. Many of these are marketed online as tools for enabling citizens to make more informed decisions about their health, wellness and lifestyle. We assessed the ‘information for consumers’ provided by these companies at the prepurchase stage, which could influence initial decisions to part with money, data or tissue samples. A scoping exercise revealed 65 DTC-GT companies advertising their services online to consumers in the United Kingdom, of which 15 met our inclusion criteria. We benchmarked their consumer information against the good practice principles developed by the UK Human Genetics Commission (HGC). No provider complied with all the HGC principles and overall levels of compliance varied considerably. Although consent for testing was discussed by all but one company, information about data reuse for research or other purposes was often sparse and consent options limited or unclear. Most did not provide supplementary support services to help users better understand or cope with the implications of test results. We provide recommendations for updating the preconsumer transparency aspects of the HGC guidelines to ensure their fitness-for-purpose in this rapidly changing market. We also recommend improving coordination between relevant governance bodies to ensure minimum standards of transparency, quality and accountability. Although DTC-GT has many potential benefits, close partnership between consumers, industry and government, along with interdisciplinary science input, are essential to ensure that these innovations are used ethically and responsibly.
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Acknowledgements
None of the authors received direct funding for this project. We thank Legal Spark, 22 Montrose Street, Glasgow G1 1RE which provided Daniel Donaldson, LLB and Sean Folan’s expertise pro bono for help with the review and for helpful discussions on the assessment criteria. And many thanks to Stuart Scott, Clinical Scientist at UKNEQAS for helpful discussions and input. External help with diagrams was supported by Vivactiv Ltd. CP is a grant holder on the ESRC-funded Administrative Data Research Centre for Scotland, Grant Number ES/L007487/1.
Author contributions
The study was conceived and designed by JAH, in collaboration with CP. JAH and JA undertook the pilot review to inform the criteria. JAH, RG, Daniel Donaldson and Sean Folan (acknowledged) conducted the full independent assessments. JAH and CP drafted the manuscript, with input from RG, which was reviewed and approved by all authors.
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Hall, J., Gertz, R., Amato, J. et al. Transparency of genetic testing services for ‘health, wellness and lifestyle’: analysis of online prepurchase information for UK consumers. Eur J Hum Genet 25, 908–917 (2017). https://doi.org/10.1038/ejhg.2017.75
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DOI: https://doi.org/10.1038/ejhg.2017.75
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