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
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.
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|Litewka, Sergio G (2010) Acta Bioeth 16:148-154|