ETHICAL ISSUES IN MULTINATIONAL CLINICAL RESEARCH

多临床研究中的伦理问题

• 批准号: 6414365
• 负责人: ezekiel J emanuel
• 金额: --
• 依托单位: CLINICAL CENTER
• 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/6414365
• 关键词: AIDS therapy; HIV infections; attitude; clinical research; clinical trials; ethics; experience; human subject; human therapy evaluation; interleukin 2; interview

This study seeks to inform deliberation and resolution of ethical issues related to multinational clinical research through interviewing various participants of the ESPRIT study. ESPRIT is a multinational collaborative clinical trial of Interleukin-2 in HIV disease. Our study will interview four groups participating in ESPRIT: (1) chairs of the Institute Review Board (IRB) or REC which reviewed ESPRIT; (2) principal investigators implementing ESPRIT; (3) persons who negotiated the Cooperative Project Assurances with the U.S. government; and (4) selected subjects participating in ESPRIT. The purpose is to compare their attitudes and experiences regarding important ethical issues associated with ESPRIT. Protocol has been reviewed by the NIAID IRB. Survey instruments are being developed and pretested.

本研究旨在通过采访ESPRIT研究的不同参与者，为跨国临床研究相关的伦理问题提供思考和解决方案。ESPRIT是一项多国合作的白细胞介素-2在HIV疾病中的临床试验。本研究将采访参与ESPRIT的四组人员：(1)负责ESPRIT评审的研究所评审委员会（IRB）或REC的主席；(2)实施ESPRIT的主要研究人员；(3)与美国政府谈判合作项目保证的人员；(4)选择参与ESPRIT的受试者。目的是比较他们对与ESPRIT相关的重要伦理问题的态度和经验。方案已由NIAID IRB审查。正在开发和预先测试调查工具。