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A 'Common Framework of Principles' for direct-to-consumer genetic tests

7 September 2009
By Emma Burton and Dr Frances Flinter
Frances Flinter is Chair of the working group for the ‘Common Framework of Principles’ for direct-to-consumer genetic testing services, Member of the Human Genetics Commission and Consultant Clinical Geneticist, Guy’s and St Thomas’s NHS Foundation Trust. Emma Burton is from the Human Genetics Commission Secretariat.
Appeared in BioNews 524
The UK's Human Genetics Commission (HGC), the Government's advisory body on new developments in human genetics and how they impact on individuals' lives, is seeking views on a 'Common Framework of Principles' for direct-to-consumer genetic tests. The Principles were developed by an international expert working group that was convened and supported by the HGC.

Direct-to-consumer genetic tests can significantly influence choices that may profoundly affect the lives of an individual and their family. Genetic tests that can provide information about health can heighten anxieties, leading individuals to make inappropriate requests for further tests, or alternatively encourage a complacent disregard for the effects of an unhealthy lifestyle. Other tests can also provoke anxieties, such as ancestry tests that offer fundamental information about identity and ethnicity. Yet, in the majority of countries, there is very little regulation of this steadily growing market and so the quality of service and the provision of support to accompany testing are determined by the test provider.

At an international meeting, in London in June 2008, there was agreement for the need for common guidelines that would address this gap in regulation and take account of the international market for direct-to-consumer genetic tests, with tests marketed and sold over the internet. The Principles therefore provide a high-level framework, having general applicability across all jurisdictions, to promote consistency and high standards in the provision of direct genetic testing services at an international level. The Principles will help to protect the interests of people seeking direct genetic tests and their families.

The Principles will apply to all situations where it is possible for a consumer to purchase a genetic test without a prescription by a qualified medical professional, including tests that are ordered directly by a consumer or a non-medical intermediary acting on the consumer's behalf. As well as genetic tests for health purposes, the Principles cover 'lifestyle', nutrigenetic and ancestry tests and tests that provide information about genetic relationships.

Test providers will be encouraged to sign up to the Principles and to work within them. The Principles cover all aspects of direct-to-consumer genetic testing services, including the marketing of services, the laboratory analysis of biological samples and the level of support that the consumer should be provided with when purchasing and receiving genetic tests results. In addition, they place an expectation on the test provider to supply easily understood, accurate, appropriate and adequate information to consumers about genetics and the role of genetics, environmental factor and lifestyle choices in determine health, diseases and other genetic traits. Claims made by test providers in promotional material and on websites about the clinical validity of tests, will need to be supported by relevant evidence published in peer reviewed scientific literature and test providers will be expected not to overstate the value or significance of genetic tests.

Although it is possible to foresee certain circumstances in which the results of virtually any genetic test could cause harm to an individual, the working group drafting the Principles formed the view that the possible harms associated with the results of some tests, generally diagnostic, predictive and carrier health tests may be greater. Therefore, the Principles will expect that tests with important implications for the health of the person concerned or their family - or with potential implications for reproductive choices - will only be provided in conjunction with both pre- and post-test counselling. In addition, for any test, where the results are likely to have a significant or potentially detrimental impact on the consumer, the test provider will be expected to consider whether the test should only be provided with support by an appropriately qualified genetics health professional.

The consultation begins on 8 September 2009 and will run until 6 December 2009. The HGC would welcome responses from any person or body with an interest in genetic testing both within the UK and abroad; whether you hold an interest in the regulation of direct-to-consumer genetic tests, are a provider of tests, or are a consumer who has considered purchasing a direct genetic test, we would welcome your responses to our consultation. For a copy of the consultation document, further information about the consultation or details of how to respond please email or visit their website.

HGC consultation on direct-to-consumer genetic testing services
HGC |  8 September 2009
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