Natural Settings Trials — Improving the Introduction of Clinical Genetic Tests

Many new genetic tests are used in clinical practice, and the number of available tests is growing. Two important health policy questions arise as these genetic tests become available. The first question, whether a new test should be made available, has been the focus of much recent discussion. The second question concerns defining the appropriate standards surrounding the use of these tests, including patient selection, education, informed consent, test interpretation and counseling.Genetic tests currently move from the research arena, where strategies are put in place to minimize risks,into the clinical context where the practice of medicine is more variable and the risks to patients less understood. In the research setting, risks can be minimized through safeguards including education, consent, and counseling. The frequency and magnitude of psychosocial and clinical risks canbe assessed. In the clinical setting, however, these safeguards may not be used consistently, creating unknown risksfor patients (see table).