Creating Collaborative Research Ethics Education with Costa Rica

描述（由申请人提供）：哥斯达黎加的高平均教育水平，独特的生物多样性，以及其成功的国家卫生系统的不断改进，使该国具有巨大的生物医学研究潜力。临床试验、流行病学研究和转化研究的商业和政府赞助者，包括美国国立卫生研究院，日益认识到这种潜力。少数国家医院和学术医疗中心已经建立了研究伦理委员会，但只有少数专业人士了解国家和国际标准，这些标准是规范国家卫生保健系统研究的新法律所要求的。来自范德比尔特大学医学中心和哥斯达黎加国家Ninos医院的一组经验丰富的研究伦理教育者将创建合作研究伦理教育（CREE）项目，以解决哥斯达黎加对正式系统的生物医学研究伦理教育和能力建设的需求，包括伦理研究的设计、实施和人类参与者研究的审查。这一系列相互关联的教育和实践培训活动将1)通过为临床和公共卫生科学的早期职业研究者量身定制的硕士课程和范德比尔特大学医学中心的研究伦理指导研究，培养哥斯达黎加生物医学研究领域的领导干部，他们在研究设计和临床和流行病学研究的道德行为方面具有深入的知识和实践技能；2)在范德比尔特大学医学中心（Vanderbilt University Medical Center）进行为期五周的研究伦理实习，培养一支哥斯达黎加研究伦理审查主任干部队伍，他们具备全面的研究伦理实践知识和方案审查、研究伦理审查委员会管理以及研究伦理指导方面的技能；3)通过在国家尼诺斯医院举办为期四天的研究伦理委员会成员课程，提高哥斯达黎加研究伦理委员会成员和管理人员在研究伦理和方案审查方面的知识和实践技能；4)增加哥斯达黎加生物医学科学教育工作者在研究伦理和负责任的研究行为（RCR）方面的知识和实践技能，通过在国家尼诺斯医院举办为期四天的研究教育工作者课程，改进他们对新研究人员的教学；5)创建、评估和分发西班牙语的研究伦理和RCR课程材料，这些材料适合中美洲的情况，可以通过开放获取网站、专业出版物和演示文稿进一步开发，用于当地、区域和跨国合作研究。这项工作将通过促进建立哥斯达黎加研究伦理教育基础设施和审查人类参与者研究方面的专门知识，在国际上促进公共卫生。

DESCRIPTION (provided by applicant): 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.