The Place of Race in Gene Patenting and Drug Development

描述（由申请人提供）：本项目的目的是探讨在基因专利和药物开发的背景下，越来越多地使用种族和民族类别的伦理和法律的后果。部分是受到联邦机构在临床试验和药物开发中收集种族和民族数据的指令的刺激，医学研究人员和制药公司越来越多地考虑种族、民族和遗传学之间的关系，特别是在新兴的药物基因组学领域。在这种背景下，我们看到一种新的现象正在出现-隐性地使用种族和基因类别来获得专利保护和药物批准。 该项目的具体目标如下： I.识别和探索现有的和正在进行的基因研究和药物开发，使用种族和/或民族作为寻求监管批准和/或专利保护的中心类别。 二.考虑专利和监管激励对种族和民族作为基础研究和药物开发类别的不断变化的影响。 三.为适当的监管机构制定一套政策和实践指南，以确保在基础研究、临床干预和药物开发中负责任和建设性地使用种族和民族类别。在审查使用种族和/或族裔的申请时，将采用这些准则，因为这些类别是基于某种遗传的基本假设。

DESCRIPTION (provided by applicant): The aim of this project is to explore the ethical and legal ramifications of the increasing use of racial and ethnic categories in the context of gene patenting and drug development. Spurred, in part, by directives from federal agencies to collect racial and ethnic data in clinical trials and drug development, medical researchers and drug companies are increasingly considering the relationship between race, ethnicity and genetics, particularly in the emerging field of pharmacogenomics. In this context, we see a new phenomenon emerging - the implicit use of race and as genetic categories to obtain patent protection and drug approval. The specific objectives of this project are the following: i. Identify and explore existing and on-going genetic research and drug development that uses race and/or ethnicity as central categories for seeking regulatory approval and/or patent protection. ii. Consider the evolving impact of patent and regulatory incentives to race and ethnicity as categories in basic research and drug development. iii. Develop a set of policy and practice guidelines for appropriate regulatory agencies to insure that categories of race and ethnicity are used responsibly and constructively in basic research, clinical interventions, and drug development. The guidelines will be employed when reviewing applications that use race and/or ethnicity in a manner that is premised upon an underlying assumption that such categories are somehow genetic.