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J Med Ethics. 2010 Dec;36(12):750-3. doi: 10.1136/jme.2009.035097. Epub 2010 Aug 26.
The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.
欧洲和拉丁美洲生物医学研究伦理监管系统项目（EULABOR）开展了首次比较分析，评估了欧洲和拉丁美洲 7 个国家的生物医学研究伦理监管系统在保护人类受试者方面的作用。我们制定了一个概念和方法框架，将“生物医学研究伦理监管系统”定义为一套监督人类生物医学研究伦理的参与者、机构、规范和法律。该框架通过对主要知情人进行半结构化访谈，为全面的国家报告提供了依据。这些报告在比较分析中进行了总结和分析。研究表明，这些国家的临床研究监管框架在范围上存在差异。尽管存在不同的政治背景、涉及的参与者和制定监管的动机，但在大多数研究国家，政府都率先建立了该体系。研究还表明，欧洲和拉丁美洲在国家机构和研究伦理委员会方面具有相似性，但巴西的体系具有强大而显著的特点。
