Framework for the sale of genetic tests direct to the public
A working group of the Commission that includes experts in regulation, clinical and molecular genetics and representatives of the genetic testing industry has now drawn up a draft framework of principles to be applied to genetic testing. Among the factors to be considered are:
- The severity of the condition being tested for and the likely impact on the person being tested
- The accuracy of prediction of a serious or life-limiting condition such as breast cancer
- The potential of results to seriously affect the behaviour of the person tested
- The ability of the test to provide health-related information about a relative or a foetus
The framework recommends that tests that fulfil these criteria to a substantial degree should be carried out only if the test provider offers access to ongoing support by providing information about opportunities for consultations with medical practitioners or genetic counsellors.
It also recommends that before a test is carried out consumers should have given free and informed consent after having received enough information for them to understand the risks, benefits and limitations of the test and the decisions that they may be faced with after taking it.
The draft framework is being circulated widely before being finalised and adopted by the Human Genetics Commission. It will then be used to inform the development of laws on the provision of genetic tests direct to the public and by industry to develop internal standards.