INFORMED CONSENT IN GENE TRANSFER RESEARCH

基因转移研究中的知情同意

• 批准号: 6436673
• 负责人: Benjamin Simon Wilfond
• 金额: --
• 依托单位: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6436673
• 关键词: behavioral /social science research tag; clinical research; gene therapy; health science research analysis /evaluation; human subject; informed consent; telecommunications

This project examines how the "benefits" of gene transfer research are described and understood by principal investigators, study coordinators, subjects, IRB chair and consent forms. One phase of this study involve telephone interviews with the principal investigator, study coordinator, 10 subjects and IRB chair in 40 studies . Currently approximately 10 sites have been enrolled. Another part of this projects involves the analysis of approximately 300 consent forms that describe gene transfer research. Approximately 35 consent forms have been coded.

本项目考察了主要研究者、研究协调员、受试者、IRB主席和同意书如何描述和理解基因转移研究的“好处”。本研究的一个阶段包括与40项研究中的主要研究者、研究协调员、10名受试者和IRB主席进行电话访谈。目前大约有10个站点已经注册。这个项目的另一部分涉及分析大约300份描述基因转移研究的同意书。大约35份同意书已经编码。