Ries Nola M, Castle David
Health Law Institute, Law Centre, University of Alberta, Edmonton AB T6G2H5, Canada.
OMICS. 2008 Dec;12(4):245-50. doi: 10.1089/omi.2008.0049.
A growing variety and number of genetic tests are advertised and sold directly to consumers (DTC) via the Internet, including nutrigenomic tests and associated products and services. Consumers have more access to genetic information about themselves, but access does not entail certainty about the implications of test results. Potential personal and public health harms and benefits are associated with DTC access to genetic testing services. Early policy responses to direct-to-consumer (DTC) genetic testing often involved calls for bans, and some jurisdictions prohibited DTC genetic tests. Recent policy responses by oversight bodies acknowledge expansion in the range of DTC tests available and suggest that a "one-size-fits-all" regulatory approach is not appropriate for all genetic tests. This review discusses ethical and regulatory aspects of DTC genetic testing, focusing particularly on nutrigenomic tests. We identify policy options for regulating DTC genetic tests, including full or partial prohibitions, enforcement of existing truth-in-advertising laws, and more comprehensive information disclosure about genetic tests. We advocate the latter option as an important means to improve transparency about current evidence on the strengths and limits of gene-disease associations and allow consumers to make informed purchasing decisions in the DTC marketplace.
越来越多不同种类的基因检测通过互联网直接向消费者（DTC）宣传和销售，包括营养基因组检测及相关产品和服务。消费者能更多地获取关于自身的基因信息，但获取信息并不意味着能确定检测结果的含义。直接面向消费者的基因检测服务可能带来个人和公共健康方面的危害与益处。早期针对直接面向消费者（DTC）基因检测的政策回应往往呼吁禁令，一些司法管辖区禁止了DTC基因检测。监管机构最近的政策回应承认了现有DTC检测范围的扩大，并表明“一刀切”的监管方法并不适用于所有基因检测。本综述讨论了DTC基因检测的伦理和监管方面，尤其关注营养基因组检测。我们确定了监管DTC基因检测的政策选项，包括完全或部分禁止、执行现有的真实广告法，以及更全面地披露基因检测信息。我们主张后一种选择是提高当前关于基因与疾病关联的证据的优势和局限性的透明度、并让消费者在DTC市场做出明智购买决策的重要手段。
