Pan American Bioethics Initiative

泛美生物伦理学倡议(PABI)计划的总体目标是挑战和使我们来自拉丁美洲和加勒比研究组织的研究员积极促进临床研究的完整性和他们研究机构负责任的研究行为。我们的研究员将是决策者和政策设计师，他们对各自机构的研究伦理计划的发展和/或监督负有实际责任。我们在拉丁美洲和加勒比地区建立研究完整性和研究能力的新方法强调“自上而下”的方法，即目前参与研究伦理法规和政策制定的决策者受到特别挑战，以制定强有力的伦理计划。期望通过同意参加Pabi，研究员们将利用迈阿密大学伦理计划、Pabi开发人员和教职员工的集体专业知识和资源，在他们的组织中制定一个强有力的研究伦理计划。与Pabi开发人员和教职员工的合作关系将最大限度地增加研究员的网络和指导机会。此外，除了研讨会和国内能力建设讲习班外，还将提供花旗计划，作为向参与组织的教职员工和学生分发基本生物伦理教育的工具。Citi计划为美国和世界各地的825多家机构提供关于人类主体保护、良好临床实践(GCP)、实验动物福利和研究诚信的网络教育。花旗计划已在秘鲁、智利、哥斯达黎加、巴西、墨西哥、波多黎各、多米尼加共和国和加勒比地区西印度群岛大学的所有场馆实施。花旗拥有一个由近60个模块组成的西班牙语和葡萄牙语语库，现在可以在新的花旗多语言课程网站上有效地展示这些模块。研究员将直接负责实施促进临床和非临床研究合乎道德和负责任的行为的计划。将每半年在巴比会议和现场讲习班上经常监测和批评进展情况。值得注意的是，该计划将持续下去，因为每个研究员将被要求在03年招募另一所院校的同行作为研究员，并参加Pabi计划。与拉丁美洲和加勒比地区现有的由Fogerty资助的项目的相当大的协同效应将是该项目的一个“增值”方面。此外，通过这项提议制定的Pabi计划将提供重要的基础设施模型和能力，将为当前和未来几年的Fogerty计划提供实质性的好处。公共热相关性：本申请中描述的泛美生物伦理倡议项目旨在积极促进拉丁美洲和加勒比资源贫乏国家的研究能力。政策制定者将面临挑战，为他们的研究人员、教职员工和学生实施严格而有力的生物伦理计划。有了这样的计划，拉丁美洲的机构将更好地参与国际临床研究企业。没有适当的伦理基础，临床研究、临床研究课题和公共卫生都不能得到很好的服务。

The overall goals of the Pan American Bioethics Initiative (PABI) program are to challenge and enable our Fellows from Latin American and Caribbean research organizations to actively foster clinical research integrity and the responsible conduct of research at their research institution. Our Fellows will be decision makers and policy architects who have practical responsibilities for the development and/or oversight of research ethics programs at their respective institutions. Our novel approach to build research integrity and research capacity in Latin America and the Caribbean emphasizes a "Top Down" approach where decision makers currently involved in research ethics regulations and policy development are specifically challenged to develop a robust ethics program. The expectation is that by agreeing to participate in the PABI, the Fellows will use the collective expertise and resources of the University of Miami Ethics Program, the PABI Developers and Faculty to develop a robust research ethic program at their organization. A collegial relationship with the PABI Developers and faculty will maximize networking and mentoring opportunities for the Fellows. In addition, to seminars and in-country capacity building workshops, the CITI Program will be provided as a tool to distribute basic bioethics education to faculty, staff and students at participating organizations. The CITI Program, offers web based education in human subject protection, Good Clinical Practice (GCP), lab animal welfare and research integrity to more than 825 institutions in the U.S. and around the world. The CITI Program has been implemented at sites in Peru, Chile, Costa Rica, Brazil, Mexico, Puerto Rico, the Dominican Republic and at all University of the West Indies venues in the Caribbean region. CITI has a Spanish and Portuguese language library of nearly 60 modules that can now be effectively presented on the new CITI mulit-language course site. Fellows will have direct responsibility for the implementation of programs that promote the ethical and responsible conduct of clinical and non-clinical research. Progress will be monitored frequently and critiqued on a semi-annual basis at the PABI meetings and at on-site workshops. Significantly, the program will be sustained because each fellow will be required to recruit, in year 03, a peer at another institution to be a Fellow and in the PABI program. Considerable synergy with existing Fogerty funded programs in Latin America and the Caribbean will be a "value added" aspect of the program. Further, the PABI program developed though this proposal will provide important infrastructure models and capabilities that will provide substantial benefits to current and future Fogerty programs for years to come. PUBLIC HEATLH RELEVANCE: The Pan American Bioethics Initiative Project described in this application is designed to aggressively promoted the research capacity in resource poor countries of Latin America and the Caribbean. Policy makers will be challenged to implement rigorous and robust bioethics programs for their investigators, staff and students. With such programs in place, institutions in the Latin America will be in a better position to participate in the international Clinical research Enerprise. Without an appropriate ethical foundation, clinical research, clinical research subjects and the public health of can not be well served.