Regulating direct-to-consumer access to genetic tests: Balancing consumer autonomy and consumer protection

A growing range of genetic tests are advertised and sold directly to consumers via the Internet, including tests for health purposes (e.g. disease susceptibility tests), tests that aim to inform lifestyle decisions (e.g. nutrigenetic tests) and non-health purposes (e.g. genealogical tests). The burgeoning availability of whole-genome sequencing means that interested consumers have increasing access to genetic information about themselves, but less certainty about implications of test results for the individual's health, life choices and relationships with biological relatives. Ethical considerations of access to genetic tests attempt to balance consumer protection concerns with consumer autonomy interests.

This presentation begins with an overview of types of direct-to-consumer (DTC) genetic testing services currently available via the Internet from companies operating in the United States and other countries. While some jurisdictions have prohibited DTC genetic tests, some groups, such as the American Society for Human Genetics and the UK Human Genetic Commission, have recently advocated that a “one-size-fits-all” regulatory approach is not appropriate for DTC genetic tests. Rather, regulation should be commensurate with risk. The presentation considers potential personal and public health harms and benefits associated with DTC genetic tests and explores emerging categorizations of genetic tests as “medical”, “lifestyle” or “recreational.” It discusses regulatory options for DTC genetic tests, including full or partial prohibitions, enforcement of existing truth-in-advertising laws, “buyer beware” educational campaigns and an unregulated marketplace. The presentation concludes with recommendations for regulating DTC genetic tests to achieve consumer protection goals while not hindering access to potentially beneficial or largely harmless services.