Costa Rica's high mean educational level, unique biodiversity, and ongoing improvement of its successful national health system give the country enormous potential for biomedical research. This potential is increasingly recognized by commercial and governmental sponsors of clinical trials, epidemiologic studies, and translational research, including the US National Institutes of Health. A few national hospitals and academic medical centers have established research ethics committees, but only a small number of professionals have the knowledge of national and international standards needed to standardize the research ethics review process called for in new laws governing research in the national health care system. A team of experienced research ethics educators from Vanderbilt University Medical Center and the Costa Rican Hospital Nacional de Ninos will create the Collaborative Research Ethics Education (CREE) program to address Costa Rica's need for formal systematic biomedical research ethics education and capacity building in ethical research design, conduct, and review of human participant research. This series of interrelated educational and practical training activities, will 1) Create a cadre of Costa Rican leaders in biomedical research with in-depth knowledge and practical skills in both research design and the ethical conduct of clinical and epidemiologic research, through tailored masters programs for early-career investigators in clinical and public health science and mentored research in research ethics at Vanderbilt University Medical Center; 2) Create a cadre of Costa Rican research ethics review directors with comprehensive practical knowledge of research ethics and skills in protocol review, administration of research ethics review committees, and instruction in research ethics, through a five-week Practicum in Research Ethics at Vanderbilt University Medical Center; 3) Enhance the knowledge and practical skills of Costa Rican research ethics committee members and administrators regarding research ethics and protocol review, through a four-day Research Ethics Committee Members Course at the Hospital Nacional de Ninos; 4) Increase the knowledge and practical skills of Costa Rican biomedical science educators in research ethics and the responsible conduct of research (RCR) to improve their teaching of new investigators, through a four-day Research Educators Course at the Hospital Nacional de Ninos; and 5) Create, evaluate, and distribute curricular materials in Spanish on research ethics and RCR that are tailored to the Central American context and that can be further developed for local, regional, and multinational collaborative research, through an open-access website and professional publications and presentations. This work will advance public health internationally by contributing to the establishment of a Costa Rican infrastructure for research ethics education and expertise in the review of human participant research. ? ? ?
