ETHICAL & LEGAL ISSUES IN THE DIFFUSION OF GENETIC TESTS

道德

• 批准号: 2208368
• 负责人: NEIL A HOLTZMAN
• 金额: $ 32.95万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-05-01 至 1998-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2208368
• 关键词: biotechnology; breast neoplasm /cancer diagnosis; diagnosis design /evaluation; diagnosis procedure safety; diagnosis quality /standard; diagnosis service; ethics; female; genetic disorder diagnosis; health behavior; health care cost /financing; health care personnel performance; health care policy; health related legal; health surveys; human subject; interview; malpractice /misconduct; prenatal diagnosis; questionnaires

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.

在未来十年中，许多基因检测将商业化。 available.这些测试的扩散速度缓慢， 更多的人将无法接触到它们。然而，如果扩散速度超过 提供测试的医生的理解，或者如果他们无视 对自主权和保密性的担忧，伤害的可能性是 增加在这个项目中，我们将研究影响医生 采用新的基因检测方法及其对如何进行检测的态度 应提供。我们还将研究发展政策， 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 提供了一个囊性纤维化的携带者测试，以医生谁采用 测试，而这项研究正在进行中，并向其他人谁还没有使用 我们将研究医生的遗传学知识的影响 和基因测试，他们对病人期望的感知 关于测试使用，他们对法律的 责任，以及他们对患者保险是否可以 支付测试费用（或者，如果没有，他们的病人是否负担得起） 他们是否真的用过这个测试 通过访谈和问卷调查，我们将了解到如何主要的医疗保健 保险公司决定何时纳入新的创新技术，例如 基因测试，在他们的福利包和什么因素影响 他们的决定 通过对生物技术公司和临床实验室的调查， 探索正在开发的组织的政策和实践 和/或提供基因测试和基因测试的程度。的 这些信息将有助于决策者决定目前是否 法规和规章足以确保安全有效 试验. 通过对有和没有家族史的消费者进行焦点小组调查 在乳腺癌中，我们将引出患者对自主性的态度， 基因测试的情况类似于那些提出的方案。我们 还将了解消费者对医生沟通方式的反应 关于基因检测的信息非裔美国妇女对 将明确考虑对乳腺癌进行基因检测。 因此，这项研究将确定偏离道德规范的程度。 新的基因检测的传播规范。它将建议特别 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。