ELSI Scale-Up: Large Sample Gene Discovery & Disclosure

描述（由申请人提供）：本提案基于这样的假设，即大样本基因发现和披露项目的快速扩展会带来重大的伦理、法律的、社会和政策挑战，以至于构成重大而紧迫的公共卫生需求。认识到这些挑战的紧迫性，并利用UNC-CH涉及大样本基因发现和披露的三个独特项目，我们请求提供为期两年的探索性（P20）赠款，以进行必要的规划，以创建一个大样本基因发现和披露的ELSI问题卓越中心。我们的目标是开发一个基础设施，以最大限度地提高合作研究，与相关选区建立伙伴关系，确定必须解决的关键问题，并收集足够的试点数据，提出一个综合性很好的中心，在其中可以进行最先进的ELSI研究，以告知公共政策。在查佩尔山的北卡罗来纳州大学（UNC-CH）的一个跨学科调查小组将与关键的外部伙伴合作，开展一系列活动，以支持五个具体目标：（1）扩大和加强跨学科调查小组，建立一个组织结构，以设计和实施对复杂和迅速出现的电子生命安全问题的多学科调查;（2）与主要成员建立伙伴关系，以促进对大样本研究中新出现的ELSI问题的共同认识，发展研究合作，并确定传播研究和影响政策和实践的有效机制;（3）利用三个主要项目收集初步数据，为即将提交的CEER申请的一部分提出的主要研究倡议做准备;（4）设计一个培训部分，使下一代的ELSI学者，基因组研究人员，临床和社会科学家，以及法律，生物伦理学和人文科学的研究人员开发独立的研究计划，解决重要的ELSI问题;和（5）充分发展卓越中心应用的愿景。

DESCRIPTION (provided by applicant): This proposal rests on the assumption that rapid expansion of large sample gene discovery and disclosure projects raise major ethical, legal, social, and policy challenges, to such an extent that it constitutes a significant and urgent public health need. Recognizing the urgency of these challenges, and drawing on three unique projects at UNC-CH involving large-sample gene discovery and disclosure, we request funding for a two-year Exploratory (P20) grant to conduct the planning necessary to create a Center of Excellence on ELSI Issues in Large Sample Gene Discovery and Disclosure. Our goal is to develop an infrastructure to maximize collaborative research, create partnerships with relevant constituencies, identify critical issues that must be addressed, and collect sufficient pilot data to propose a well-integrated center in which state-of-the-art ELSI research can be conducted to inform public policy. An interdisciplinary group of investigators at the University of North Carolina at Chapel Hill (UNC-CH), in partnership with key external partners, will engage in a range of activities to support five specific aims: (1) expand and strengthen an interdisciplinary team of investigators, creating an organizational structure to design and implement multi-disciplinary investigations of complex and rapidly emerging ELSI issues; (2) establish partnerships with key constituents to facilitate joint awareness of emerging ELSI issues in large sample studies, develop research collaboration, and identify effective mechanisms to disseminate research and influence policy and practice; (3) use three major projects to collect preliminary data in preparation for major research initiatives to be proposed as part of a forthcoming CEER application; (4) design a training component to enable the next generation of ELSI scholars, genome researchers, clinical and social scientists, and researchers in law, bioethics and the humanities to develop independent research programs that address important ELSI problems; and (5) fully develop a vision for a Center of Excellence application.