A Comparative Study Of Ethical Issues In Multinational C

跨国公司伦理问题的比较研究

• 批准号: 6675303
• 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/6675303
• 关键词: AIDS therapy; HIV infections; attitude; behavioral /social science research tag; clinical research; clinical trials; ethics; experience; health care service evaluation; health science research analysis /evaluation; health services research tag; health surveys; human subject; interleukin 2; international cooperation; interview; method development; perception; questionnaires

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 is interviewing 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. There has been substantial controversy about the ethics of human subjects research in developing countries. This study is designed to provide an ethical framework for clinical research in developing countries and investigate empirically some of the more controversial issues in this research. Still conducting interviews with IRB chairs, PIs, and research participants in several countries.

这项研究旨在通过采访ESPRIT研究的不同参与者，为审议和解决与跨国临床研究有关的伦理问题提供信息。ESPRIT是一项治疗HIV疾病的IL-2的跨国协作临床试验。我们的研究访问了参与ESPRIT的四个群体：(1)审查ESPRIT的研究所审查委员会(IRB)或REC的主席；(2)实施ESPRIT的主要调查人员；(3)与美国政府谈判达成合作项目保证的人；以及(4)参与ESPRIT的选定受试者。目的是比较他们在与ESPRIT相关的重要伦理问题上的态度和经验。在发展中国家，人类受试者研究的伦理问题一直存在很大争议。这项研究旨在为发展中国家的临床研究提供一个伦理框架，并对这项研究中一些更具争议性的问题进行实证研究。仍在几个国家与IRB主席、私人投资经理和研究参与者进行面谈。