From Specimen to Biobank: Using an Organizational Perspective to Study ELSI Issue

描述(由申请者提供)：本研究项目将收集和分析有关美国生物库的定性和定量数据，探索组织战略、特征和属性如何影响ELSI和政策选择的框架和响应。我们认为，生物库的组织特征直接影响政策选择，以及成员对ELSI的框架和反应，进而影响政策选择。我们将选择12个具有不同创建策略的生物库(从头开始创建收藏，重新调整非研究收藏的用途，并将现有的标本收藏联网)，以探索性地深入研究它们的历史、演变以及对ELSI和政策选择的反应。利用案例研究的结果，我们将提炼关于组织战略、特征和属性、ELSI和政策选择之间关系的问题和假设，以便为从系统抽样框架中挑选出的500名生物库管理人员进行调查提供信息。作为调查的后续行动，将对50名报告了关键领域不同政策选择的行政人员进行访谈，以进一步探讨我们的调查结果。基于这两个目标的数据，我们将向一组生物库利益相关者提出政策建议，并使用德尔菲法，我们将就提交给政策制定者和美国生物库社区的指导方针达成共识。 公共卫生相关性：这是一项对组织的研究，称为“生物库”，收集、存储、管理和共享人体样本，如血液或组织，以进行健康研究为目的。由于这是一个新的快速发展的行业，了解生物库如何应对依赖于这种长期储存和使用的基因研究产生的伦理、法律和政策问题是很重要的。我们将采访在这些组织工作的人，了解他们的经历，以便就解决这些问题的最佳方法提出建议。

DESCRIPTION (provided by applicant): This research project will collect and analyze qualitative and quantitative data about US biobanks, exploring how organizational strategies, features, and attributes affect both framing and response to ELSI and policy choices. We argue that a biobank's organizational features impact 1) policy choices directly, and 2) members' framing and response to ELSI which in turn impact policy choices. We will select 12 biobanks with diverse creation strategies (creating collections from the "ground up" (de novo), repurposing non-research collections, and networking existing specimen collections) for exploratory in-depth case studies of their history, evolution, and response to ELSI and policy choices. Using the results of the case studies, we will refine questions and hypotheses about the relationships between organizational strategies, features, and attributes, ELSI, and policy choices in order to inform a survey of 500 biobank administrators selected from a systematic sampling frame. As a follow-up to the survey, interviews with 50 administrators who reported different policy choices in key areas will be conducted to further explore our findings. Based on data from these two AIMS, we will present policy recommendations to a group of biobank stakeholders, and using a Delphi process, we will develop consensus about guidelines to present to policy makers and the US biobank community. PUBLIC HEALTH RELEVANCE: This is a study of organizations, called "biobanks," that collect, store, manage, and share human samples, such as blood or tissue, for the purpose of conducting health research. Because this is a new and rapidly evolving industry, it is important to understand how biobanks respond to ethical, legal, and policy concerns that arise from genetic research that relies upon such long term storage and use. We will interview people who work in these organizations about their experiences, in order to make recommendations about the best ways to resolve these concerns.