Pan American Bioethics Initiative

泛美生物伦理倡议

• 批准号: 7544872
• 负责人: PAUL G BRAUNSCHWEIGER
• 金额: $ 23.11万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-23 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7544872
• 关键词: American; Bioethics; Brazil; Caribbean natives; Caribbean region; Chile; Clinical; Clinical Research; Costa Rica; Country; Critiques; Development; Dominican Republic; Education; Educational workshop; Ethics; Faculty; Fostering; Foundations; Funding; Future; Goals; Institution; International; Language; Latin America; Libraries; Mentors; Mexico; Modeling; Monitor; Online Systems; Pan Genus; Personal Satisfaction; Peru; Policy Developments; Policy Maker; Positioning Attribute; Public Health; Puerto Rico; Recruitment Activity; Regulation; Research; Research Ethics; Research Infrastructure; Research Personnel; Research Subjects; Resources; Site; Students; Universities; West Indies; animal welfare research; base; design; development policy; expectation; human subject; novel strategies; peer; programs; tool

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：泛美生物伦理倡议 (PABI) 计划的总体目标是挑战并使我们来自拉丁美洲和加勒比海研究组织的研究员能够积极促进临床研究的完整性和在其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制定者，他们对各自机构的研究伦理项目的制定和/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诚信和研究能力的新颖方法强调“自上而下”的方法，目前参与研究伦理法规和政策制定的决策者面临着制定强有力的伦理计划的特别挑战。我们期望，通过同意参与 PABI，研究员将利用迈阿密大学道德计划、PABI 开发人员和教员的集体专业知识和资源，在其组织中制定强大的研究道德计划。与 PABI 开发人员和教师的合作关系将为研究员提供最大程度的交流和指导机会。此外，除了研讨会和国内能力建设讲习班外，CITI 计划还将作为向参与组织的教职员工和学生提供基本生物伦理学教育的工具。 CITI 计划为美国和世界各地超过 825 个机构提供有关人类受试者保护、良好临床实践 (GCP)、实验动物福利和研究诚信的网络教育。 CITI 计划已在秘鲁、智利、哥斯达黎加、巴西、墨西哥、波多黎各、多米尼加共和国的校区以及加勒比地区的所有西印度群岛大学校区实施。 CITI 拥有包含近 60 个模块的西班牙语和葡萄牙语语言库，现在可以在新的 CITI 多语言课程网站上有效呈现。研究员将直接负责实施促进临床和非临床研究的道德和负责任行为的计划。将经常监测进展情况，并每半年在 PABI 会议和现场研讨会上进行批评。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第 03 年招募另一机构的同行成为研究员并加入 PABI 计划。与拉丁美洲和加勒比地区现有的福格蒂资助项目的显着协同作用将是该项目的“增值”方面。此外，通过该提案开发的 PABI 计划将提供重要的基础设施模型和功能，这些模型和功能将为当前和未来的 Fogerty 计划在未来几年带来实质性好处。公共卫生相关性：本申请中描述的泛美生物伦理倡议项目旨在积极提高拉丁美洲和加勒比地区资源匮乏国家的研究能力。政策制定者将面临为其研究人员、工作人员和学生实施严格而有力的生物伦理计划的挑战。有了这些计划，拉丁美洲的机构将能够更好地参与国际临床研究 Enerprise。没有适当的伦理基础，临床研究、临床研究对象和公众健康就无法得到很好的服务。