ETHICAL & LEGAL ISSUES IN THE DIFFUSION OF GENETIC TESTS

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During the next decade many genetic tests will become commercially available. A slow rate of diffusion of these tests prolongs inequity, as more people will not have access to them. If, however, diffusion outpaces the understanding of physicians offering the tests, or if they disregard concerns about autonomy and confidentiality, the chance of harm is increased. In this project, we will study factors influencing physicians' adoption of new genetic tests and their attitudes towards how tests should be provided. We will also study policies for developing and providing genetic tests and begin to explore consumer attitudes. By mailed questionnaire, we will compare physicians who have already offered a carrier test for cystic fibrosis to physicians who adopt the test while this study is in progress and to others who have not yet used it. We will examine the influence of physicians' knowledge of genetics and genetic tests, their perception of their patients' expectations regarding test use, their experience with and concerns about legal liability, and their sensitivity to whether their patients' insurance can pay for the test (or, if not, whether their patients can afford it) on whether they have actually used this test. By interviews and questionnaires, we will learn how major health care insurers decide when to include new innovative technologies, such as genetic tests, in their benefits packages and what factors influence their decisions. By a survey of biotechnology companies and clinical laboratories, we will explore policies and practices of organizations that are developing and/or providing genetic tests and the extent of genetic testing. The information will assist policy makers in deciding whether current statutes and regulations are adequate to assure safe and effective testing. By conducting focus groups of consumes with and without a family history of breast cancer, we will elicit patient attitudes toward autonomy under genetic test situations similar to those presented in the scenarios. We will also learn consumers' reactions to the ways physicians communicate information on genetic tests. Attitudes of African-American women toward genetic tests for breast cancer will be explicitly considered. The study will, therefore, identify the extent of departures from ethical norms in the diffusion of new genetic tests. It will suggest particular situations in which remedial educational interventions or policy changes could improve the safe and effective delivery of genetic tests.