Creating Collaborative Research Ethics Education with Costa Rica

描述(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完善，使该国在生物医学研究方面具有巨大的潜力。临床试验、流行病学研究和转化研究的商业和政府赞助商，包括美国国立卫生研究院，越来越认识到这一潜力。一些国立医院和学术医学中心已经成立了研究伦理委员会，但只有少数专业人员了解国家和国际标准，以规范国家医疗保健系统研究的新法律要求的研究伦理审查过程。来自范德比尔特大学医学中心和哥斯达黎加国家尼诺斯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)计划，以满足哥斯达黎加在伦理研究设计、实施和人类参与研究审查方面对正规、系统的生物医学研究伦理教育和能力建设的需求。这一系列相互关联的教育和实践培训活动，将1)通过范德比尔特大学医学中心为临床和公共卫生科学的早期职业调查人员量身定做的硕士课程和研究伦理指导研究，培养一支在研究设计以及临床和流行病学研究的伦理指导方面具有深入知识和实践技能的哥斯达黎加生物医学研究领导干部；2)通过范德比尔特大学医学中心为期五周的研究伦理实践，培养一支具有全面研究伦理实践知识和在方案审查、研究伦理审查委员会管理和研究伦理指导方面的哥斯达黎加研究伦理审查主任干部；3)通过在尼诺斯国家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)通过在尼诺斯国家医院举办为期四天的研究教育者课程，提高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方面的知识和实践技能，以改进他们对新调查人员的教学；以及5)创建、评估和分发西班牙语的研究伦理和研究报告课程材料，这些材料是根据中美洲的情况量身定做的，可以通过一个开放获取的网站以及专业出版物和演示文稿，为当地、区域和多国合作研究进一步开发。这项工作将推动哥斯达黎加建立研究、道德、教育和审查人类参与研究方面的专门知识的基础设施，从而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.