ETHICAL & LEGAL ISSUES IN THE DIFFUSION OF GENETIC TESTS

在接下来的十年里，许多基因测试将商业化 可用。这些测试的缓慢扩散速度延长了不平等，因为 将有更多的人无法访问它们。然而，如果扩散速度超过 医生对提供检测的理解，或者他们是否无视 出于对自主性和保密性的担忧，伤害的可能性是 增加了。在这个项目中，我们将研究影响医生 采用新的基因测试及其对如何测试的态度 应该提供。我们还将研究发展和发展的政策 提供基因测试，并开始探索消费者的态度。 通过邮寄问卷，我们将比较已经 为那些采用了 在这项研究进行期间进行测试，并向其他尚未使用 它。我们将考察医生的遗传学知识的影响 以及基因测试，他们对患者期望的感知 关于测试使用，他们对法律的经验和担忧 责任，以及他们对患者保险是否可以 支付测试费用(或者，如果不是，支付他们的患者是否负担得起) 他们是否真的用过这个测试。 通过访谈和问卷调查，我们将了解主要的医疗保健是如何 保险公司决定何时纳入新的创新技术，如 基因测试，在他们的福利方案中，以及哪些因素影响 他们的决定。 通过对生物技术公司和临床实验室的调查，我们将 探索正在开发的组织的政策和实践 和/或提供基因检测和基因检测的程度。这个 信息将帮助政策制定者决定当前 法律法规足以确保安全和有效 测试。 通过对有家族史和无家族史的消费者进行焦点小组调查 对于乳腺癌，我们将在以下条件下诱导患者对自主的态度 基因测试的情况与场景中出现的情况类似。我们 还将了解消费者对医生沟通方式的反应 关于基因测试的信息。非裔美国女性对 乳腺癌的基因测试将被明确考虑。 因此，这项研究将确定偏离道德的程度 在推广新的基因测试方面的规范。它将暗示特定的 补救性教育干预或政策改变的情况 可以提高基因检测的安全性和有效性。

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.