Table 2

Four positions on clinical validity and regulatory requirements

Does personal genome testing have clinical validity?


Yes (or some)

No (or not sufficiently)


Does personal genome testing require regulation?

Yes

Because of potentially adverse health impact, and psychological and societal risks, personal genome testing ought to be made available only under medical supervision

Because of the risks of over-interpretation and subsequent health risks, personal genome testing ought not to be allowed on the market


No

The risks are only minor, whereas access to (potentially or partly) useful genetic information is important and ought not to be hindered by regulatory restrictions

Personal genome testing is to be considered an informational or recreational product: consumer information is sufficient to regulate the market and to protect consumers from any risks


Bunnik et al. BMC Medical Ethics 2011 12:11   doi:10.1186/1472-6939-12-11

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