A Comparative Study Of Ethical Issues In Multinational C

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伦理问题的审议和解决提供信息。ESPRIT是一项关于白细胞介素-2在HIV疾病中的多国合作临床试验。我们的研究采访了四个参与ESPRIT的群体：（1）审查ESPRIT的研究所审查委员会（IRB）或REC的主席;（2）实施ESPRIT的主要研究者;（3）与美国政府谈判合作项目Asphalt的人;（4）参与ESPRIT的选定受试者。其目的是比较他们的态度和经验的重要伦理问题与ESPRIT。在发展中国家，关于人类受试者研究的伦理问题一直存在很大争议。本研究旨在为发展中国家的临床研究提供一个伦理框架，并对该研究中一些更具争议性的问题进行实证调查。仍在与几个国家的IRB主席、PI和研究参与者进行访谈。

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.