The Place of Race in Gene Patenting and Drug Development

种族在基因专利和药物开发中的地位

基本信息

批准号：
7255141
负责人：
JONATHAN KAHN
金额：
$ 7.43万
依托单位：
HAMLINE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-07-01 至 2009-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7255141
关键词：
Address African American Attention Automobile Driving Basic Science Bidil Biological Categories Class Clinical Clinical Trials Complex Condition Data Depth Development Drug Approval Drug Approval Processes Drug usage Electronic library Ethnic Origin Ethnic group Faculty Federal Government Fostering Gender Genes Genetic Genetic Materials Genetic Research Genetic Variation Gold Grant Guidelines Haplotypes Healthcare Heart Diseases Heart failure Human Genetics Human Genome Project Incentives Individual International Intervention Journals Knowledge Laws Lawyers Legal Legal patent Maps Marketing Medical Methodology Methods Nature Paper Pathology Patients Peer Review Pharmaceutical Preparations Pharmacogenomics Policies Population Population Genetics Practice Guidelines Principal Investigator Process Production Protocols documentation Publishing Race Research Research Personnel Resources Safety Schools Series Shapes Site Staging Subgroup Testing Therapeutic Intervention Time Trademark United States Dept. of Health and Human Services United States Food and Drug Administration United States National Institutes of Health Universities Wood material base drug development drug metabolism ethical legal social implication experience innovation racial and ethnic response social

项目摘要

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.

描述（由申请人提供）：该项目的目的是探讨基因专利和药物开发的种族和种族类别日益使用的道德和法律影响。医学研究人员和制药公司越来越多地考虑到临床试验和药物开发中收集种族和族裔数据的指令，部分原因是，医学研究人员和制药公司越来越多地考虑种族，种族和遗传学之间的关系，尤其是在药物基因组学的新兴领域。在这种情况下，我们看到了一种新现象的新现象 - 种族的隐含使用，并作为获得专利保护和药物批准的遗传类别。该项目的具体目标如下：我。识别并探索现有和正在进行的遗传研究和药物开发，这些研究和药物开发将种族和/或种族用作寻求监管部门批准和/或专利保护的中心类别。 ii。将专利和监管激励措施对种族和种族的不断发展的影响作为基础研究和药物开发中的类别。 iii。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地和建设性地使用种族和种族类别。在审查使用种族和/或种族的申请时，将采用该准则，以一种基本假设为前提的方式，即这种类别是某种程度上是遗传的。