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.

拟议研究的总体目标是研究药物反应性遗传变异的伦理、法律和社会影响，特别是在种族、民族和性别方面发现显着差异的情况。 该研究将重点关注四个要素：1）药物基因组学当前和未来潜在的用途，以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的医疗保健方面的作用以及管理式医疗组织对药物基因组处方药物的预期反应，包括与药物基因组药物的实验性质、覆盖要求和成本节约相关的问题； 4) 药物基因组学对适用于医生和药剂师向患者提供有关某些药物治疗的遗传不耐受或相容性建议的法律和伦理标准的影响。 研究设计将包括传统法律、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，以确定不同种族和族裔群体如何看待药物基因组学，以及他们在根据药物反应性遗传变异进行诊断测试或同意服用药物之前需要了解什么； 2) 主办一次会议，聚集主要参与者，研究和讨论药物基因组学的伦理、法律和社会影响； 3) 出版一本讨论药物基因组学影响的书，特别是它与种族、民族和性别有关的影响，并为正确使用科学提出指导方针； 4) 发表两篇论文，一篇关于科学的未来，一篇关于调查结果。