PHARMACOGENOMICS AND MINORITY POPULATIONS

拟议研究的总体目标是研究药物反应基因变异的伦理、法律和社会影响，特别是在基于种族、民族和性别发现显著差异的情况下。这项研究将集中在四个方面：1)药物基因组学目前和未来用于确定某些药物的安全性和有效性；2)药物基因组学对药物试验中招募和使用人类受试者适用的法律标准的影响，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受管理的医疗机构对药物基因组处方药物的预期反应，包括与基于药物基因组的药物的实验性质、覆盖范围和成本节约有关的问题；以及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，这些标准适用于向患者建议某些药物疗法的遗传不耐受或相容。研究设计将包括传统法律、医学、社会科学和生命伦理学的研究和分析。研究结果将被用于：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根据药物反应基因变异服用药物之前需要知道什么；2)主办一次会议，将主要参与者聚集在一起，审查和讨论药物基因组学的伦理、法律和社会影响；3)出版一本书，讨论药物基因组学的含义，特别是当它涉及种族、民族和性别时，并提出正确使用科学的指导方针；4)发表两篇论文，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.