PHARMACOGENOMICS AND MINORITY POPULATIONS

药物基因组学和少数民族人群

• 批准号: 6442865
• 负责人: MARK A ROTHSTEIN
• 金额: $ 18.52万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-01-01 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6442865
• 关键词: behavioral /social science research tag; clinical research; drug screening /evaluation; ethics; ethnic group; gender difference; health care policy; health care service availability; health related legal; human subject; informed consent; medical outreach /case finding; pharmacogenetics; publications; racial /ethnic difference; social adjustment; social behavior; statistics /biometry

The overall objective of the proposed research is to study the ethical, legal, and social implications of drug responsive genetic variations, especially where significant differences have been found based upon race, ethnicity, and gender. The research will focus on four elements: 1) the current and potential future use of pharmacogenomics to establish the safety and efficacy of certain drugs; 2) the impact of pharmacogenomics on the legal standards applicable to the recruitment and use of human subjects in drug trials, including issues of diversity, informed consent, and confidentiality; 3) the role of pharmacogenomics in providing access to appropriate health care for certain groups and the anticipated response of managed care organizations to pharmacogenomic-prescribed drugs, including issues related to the experimental nature of pharmacogenomic-based drugs, coverage mandates, and cost savings; and 4) the impact of pharmacogenomics on the legal and ethical standards of care applicable to physicians and pharmacists in advising patients about genetic intolerance to or compatibility with certain drug therapies. The research design will consist of traditional legal, medical science, social science, and bioethics research and analysis. The results of the research will be used to: 1) conduct a survey to determine how various racial and ethnic groups view pharmacogenomics and what they would need to know before submitting to a diagnostic test or agreeing to take drugs based upon drug responsive genetic variation; 2) host a conference that brings together the key players to examine and discuss the ethical, legal, and social implications of pharmacogenomics; 3) publish a book that discusses the implications of pharmacogenomics, especially as it relates to race, ethnicity, and gender, and that sets forth guidelines for the proper use of the science; and 4) publish two papers, one on the future of the science and one on the survey results.

拟议的研究的总体目标是研究药物反应式遗传变异的道德，法律和社会含义，尤其是在基于种族，种族和性别发现的显着差异的情况下。 该研究将重点关注四个要素：1）药物基因组学目前和潜在的未来使用来确定某些药物的安全性和功效； 2）药物基因组学对适用于招募和使用人类受试者的法律标准的影响，包括多样性，知情同意和机密性问题； 3）药物基因组学在为某些群体提供适当医疗保健方面的作用，以及托管护理组织对药物基因组规定药物的预期反应，包括与基于药物基因组的药物的实验性质有关的问题，覆盖范围授权和成本节省； 4）药物基因组学对适用于医生和药剂师的法律和道德护理标准的影响，向患者提供有关某些药物疗法的遗传不耐受或兼容的建议。 研究设计将包括传统的法律，医学，社会科学和生物伦理学研究和分析。研究结果将用于：1）进行调查，以确定各种种族和族裔如何查看药物基因组学以及在服从诊断测试之前需要了解的内容，或同意根据药物反应性遗传变异来服用药物； 2）举办一次会议，汇集了主要参与者，以检查和讨论药物基因组学的道德，法律和社会影响； 3）出版一本讨论药物基因组学的含义的书，尤其是与种族，种族和性别有关的书，并制定了适当使用科学的准则； 4）发表两篇论文，一篇关于科学的未来，另一篇关于调查结果。