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

从样本到生物样本库：使用组织视角研究 ELSI 问题

• 批准号: 7984662
• 负责人: Gail E HENDERSON
• 金额: $ 60.31万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-27 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7984662
• 关键词: Accounting; Address; Administrator; Adopted; Adoption; Affect; Area; Awareness; Blood; Case Study; Collection; Communities; Consensus; Consent; Data; Disclosure; Electronics; Environment; Equipment and supply inventories; Ethics; Evolution; Genetic; Genetic Research; Goals; Government; Guidelines; Health; Health Policy; Human; Incidental Findings; Individual; Industry; Interview; Legal; Literature; Measures; Mission; Ownership; Policies; Policy Maker; Positioning Attribute; Process; Public Domains; Public Health; Recommendation; Recording of previous events; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Rights; Sampling; Shapes; Specific qualifier value; Specimen; Standardization; Structure; Surveys; Technology; Testing; Time Factors; Tissues; Variant; Work; base; biobank; design; ethical legal social implication; experience; falls; follow-up; instrument; member; policy implication; prevent; public health relevance; research study; response; sample collection; tool

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.

描述（由申请人提供）：本研究项目将收集和分析有关美国生物银行的定性和定量数据，探索组织策略，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，一个生物银行的组织特征影响1）政策选择直接，和2）成员的框架和响应ELSI反过来影响政策选择。我们将选择12个具有不同创建策略的生物银行（从“地面”（从头开始）创建集合，重新利用非研究集合，并将现有标本集合联网），以探索其历史，演变和对ELSI和政策选择的响应的深入案例研究。利用案例研究的结果，我们将完善组织战略，功能和属性，ELSI和政策选择之间的关系的问题和假设，以告知从系统抽样框架中选择的500个生物银行管理员的调查。作为调查的后续行动，将对50名报告在关键领域有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。根据这两个AIMS的数据，我们将向一组生物库利益相关者提出政策建议，并使用德尔菲程序，我们将就提交给政策制定者和美国生物库社区的指南达成共识。 公共卫生关系：这是一项对被称为“生物库”的组织的研究，这些组织收集、储存、管理和共享人类样本，如血液或组织，以进行健康研究。因为这是一个新的和快速发展的行业，重要的是要了解生物库如何应对伦理，法律的，以及依赖于这种长期存储和使用的遗传研究所产生的政策问题。我们将采访在这些组织中工作的人，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。