PHARMACOGENOMICS AND MINORITY POPULATIONS

拟议研究的总体目标是研究药物敏感性遗传变异的伦理、法律的和社会影响，特别是在基于人种、种族和性别发现显著差异的情况下。 该研究将集中在四个要素：1）药物基因组学的当前和潜在的未来使用，以确定某些药物的安全性和有效性; 2）药物基因组学对适用于药物试验中招募和使用人类受试者的法律的标准的影响，包括多样性，知情同意和保密问题; 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，以及管理式医疗组织对药物基因组学处方药物的预期反应，包括与药物基因组学药物的实验性质有关的问题，覆盖任务，节约成本;和4）药物基因组学对适用于医生和药剂师的法律的和伦理的护理标准的影响，以告知患者对某些药物疗法的遗传不耐受性或相容性。 研究设计将包括传统的法律的、医学、社会科学和生物伦理学的研究和分析。研究结果将用于：1）进行一项调查，以确定不同种族和民族如何看待药物基因组学，以及他们在接受诊断测试或同意服用基于药物反应性遗传变异的药物之前需要知道什么; 2）举办一次会议，汇集主要参与者，研究和讨论药物基因组学的伦理、法律的和社会影响; 3）出版一本书，讨论药物基因组学的影响，特别是当它涉及到种族，民族和性别，并提出正确使用科学的指导方针;和4）出版两篇论文，一篇关于科学的未来，一篇关于调查结果。

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.