Guidelines to regulate consumer gene tests internationally drawn up by UK body

The principles have been drawn up by a group of international experts, including representatives of gene testing companies, chaired by Frances Flinter of the HGC. The principles set out in such a way that they can be adapted to suit different national regulatory regimes, allowing them to be adopted internationally and making it easier to regulate gene tests.

At present, direct to consumer testing services, many of which are offered over the Internet by foreign suppliers, are largely unregulated. The market is growing rapidly and there is concern that individuals are both getting false reassurances, or suffering unnecessary anxiety, if tests are not accompanied by appropriate medical advice.

Tests range from paternity testing, to genome-wide scans that calculate genetic risk for different cancers and cardio vascular diseases conditions, to tests for specific diseases such as Huntington’s disease.

The framework published by the Human Genetics Commission requires companies to follow basic principles of consent, data protection, verifiable marketing, scientific rigor and balanced interpretation of results.

“To cover this international market we need a set of off-the-shelf principles that can be used everywhere,” Flinter said. “Some tests can cause considerable surprise or concern to those taking them, or give false reassurance. Some are of doubtful value, to say the least.

The framework is the result of a consultation which the HGC began in June 2008 when it convened a meeting of service providers, patient representatives, professional bodies and others, from around the world to discuss the state of the market and to share concerns. There was agreement that there needed to be common international guidelines to promote standards and protect consumers.

Following this, HGC brought together the expert group. It claims the principles developed as a result represent a high level of consensus on what constitutes good practice. They not only provide rules for companies and regulators, but aim to guide and educate consumers in how tests work, and how they should be used. The principles encompass marketing and advertising, information for consumers, consent, analysis of biological samples and the level of counselling that should accompany different kinds of tests.

‘A Common Framework of Principles for direct-to-consumer genetic testing services,’ is available at the UK Human Genetics Commission website.