DNA image courtesy NIH
The Commission, which is the UK government advisor on genetic advances, has published a Consultation on a Common Framework of Principles for direct-to-consumer genetic testing services and is inviting comments.
Frances Flinter, the HGC Commissioner who chaired the working group that developed the principles, said, “Direct-to-consumer tests covering everything from hereditary illnesses to ancestry research have multiplied significantly in recent years. Many of these tests are provided over the Internet by companies [based abroad], or over the counter in shops and pharmacies, without advice from clinically trained professionals and with little in the way of regulation.”
“Some tests can cause considerable surprise or concern to those taking them – or give false reassurance. Some, to say the least, are of doubtful value. We need a set of principles that can be adopted within existing legal frameworks in different countries.”
The principles have been developed in conjunction with representatives from the genetic testing industry to promote high standards and consistency amongst commercial providers at an international level. As such, said Flinter, they represent a high degree of consensus about what constitutes good practice. “They offer a guide to consumers, as well as service providers and regulators, about the elements that should make up a good quality direct genetic testing service. This consultation will give all those who have an interest in direct genetic testing the opportunity to influence the final version.”
The principles cover all aspects of direct-to-consumer genetic testing services including the marketing and advertising of tests, information for consumers, consent, the laboratory analysis of biological samples and the levels of support that should accompany the genetic test results.
Purchasers of tests need to be aware of possible outcomes – what they might expect to find out and what they can do about it.
Tests for serious hereditary diseases such as Huntington’s disease should only be provided with before and after counselling.
People requesting tests should be provided with simple easy to understand information on how genetic testing works and what the results mean.
Companies should always make clear the limitations of the tests they provide and the relative roles of genetic makeup and lifestyle.
Companies offering services must take steps to keep DNA samples and genetic information secure, and to ensure that they have the consent of the sample provider to perform the tests.
The consultation runs until 6 December 2009.
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