Ethical Issues In Multinational Clinical Research

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。在发展中国家，关于人类受试者研究的伦理问题一直存在大量争议。本研究旨在为发展中国家的临床研究提供一个伦理框架，并对本研究中一些比较有争议的问题进行实证调查。与非洲临床研究人员一起，我们正在研究什么构成临床研究的利益以及什么水平的利益是伦理多国研究所必需的问题。同样，我们正在努力确定一套完整的原则和基准，为确定发展中国家的临床研究何时合乎伦理提供一个总体框架。实证研究的重点是非洲国家的受试者是否被强迫参与研究，他们是否了解研究的细节，包括研究的风险和收益，以及临床研究的参与者如何感知研究的好处

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. 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. In conjunction with African clinical researchers we are examining the question of what constitutes benefits of clinical research and what level of benefits are necessary for ethical multi-national research. Similarly we are trying to define a full set of principles and benchmarks to provide a general framework for determining when clinical research in developing countries is ethical. The empirical research is focusing on whether subjects in African countries are coerced into participating in research, whether they understand the details, including the risks and enefits, of the research and how participants in clinical research perceive the benefits of the research