Creating Collaborative Research Ethics Education with Costa Rica

与哥斯达黎加创建合作研究伦理教育

• 批准号: 7472544
• 负责人: ELIZABETH HEITMAN
• 金额: $ 22.32万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-18 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7472544
• 关键词: Academic Medical Centers; Address; Administrator; Biodiversity; Biomedical Research; Central American; Classification; Clinical; Clinical Trials; Costa Rica; Costa Rican; Country; Depth; Education; Educational Status; Educational process of instructing; Epidemiologic Studies; Ethics; Health Sciences; Health system; Healthcare Systems; Hospitals; Human; Instruction; International; Knowledge; Laws; Mentors; Numbers; Participant; Process; Protocols documentation; Public Health; Publications; Research; Research Design; Research Ethics; Research Ethics Committees; Research Infrastructure; Research Personnel; Review Committee; Science; Series; Standards of Weights and Measures; Training Activity; Translational Research; United States National Institutes of Health; Week; Work; career; day; experience; improved; member; programs; skills

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.

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持续改进，为该国带来了生物医学研究的巨大潜力。商业和政府赞助商的临床试验，流行病学研究和转化研究（包括美国国家卫生研究院）越来越多地认可了这种潜力。一些国家医院和学术医疗中心已经成立了研究伦理委员会，但是只有少数专业人员了解了在国家医疗保健系统中掌管研究的新法律中所要求的国家和国际标准所需的国家和国际标准。来自范德比尔特大学医学中心和哥斯达黎加医院Nacional de Ninos的经验丰富的研究道德教育者团队将创建合作研究伦理教育（CREE）计划，以满足哥斯达黎加对人类参与者研究，行为和审查人类参与者研究中正式系统生物医学研究伦理学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）通过为临床和公共卫生科学和公共健康科学研究中的早期研究人员研究人员的临床和流行病学研究创建哥斯达黎加的生物医学研究领导者，并在研究设计以及临床和流行病学研究的伦理学方面具有深入的知识和实践技能，并在研究设计中具有深入的知识和实践能力。 2）创建哥斯达黎加研究伦理学审查总监，并通过范德比尔特大学医学中心的五周研究伦理学实践，对协议审查的研究道德和技能的全面实践知识，研究伦理审查委员会的管理和研究伦理学的教学； 3）通过为期四天的研究伦理委员会成员课程在医院Nacional de Ninos举办的为期四天的研究伦理和协议审查，提高哥斯达黎加研究伦理委员会成员和管理人员的知识和实践技能； 4）通过在Nacional Nacional de Ninos举办的为期四天的研究教育工作者课程，提高了研究伦理学和负责任的研究伦理学（RCR）的知识和实践技能； 5）在研究道德和RCR上创建，评估和分发西班牙语的课程材料，这些材料是针对中美洲背景的，可以通过开放式访问网站以及专业出版物以及演讲和演示来为本地，地区和跨国协作研究而进一步开发。这项工作将通过为研究伦理教育的哥斯达黎加基础设施建立哥斯达黎加基础设施而在国际上提高公共卫生，并在人类参与者研究中建立专业知识。