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: 7288730
• 负责人: ELIZABETH HEITMAN
• 金额: $ 19.7万
• 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/7288730
• 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）：哥斯达黎加较高的平均教育水平、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，赋予该国生物医学研究巨大的潜力。这种潜力越来越受到临床试验、流行病学研究和转化研究的商业和政府赞助商的认可，其中包括美国国立卫生研究院。一些国家医院和学术医疗中心设立了研究伦理委员会，但只有少数专业人员了解规范国家医疗保健系统研究新法律所要求的研究伦理审查程序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国家儿童医院的经验丰富的研究伦理教育工作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正式系统生物医学研究伦理教育和伦理研究设计能力建设的需求、进行和审查人类参与者研究。这一系列相互关联的教育和实践培训活动将： 1) 通过为哥斯达黎加量身定制的硕士课程，培养一支由哥斯达黎加生物医学研究领域的领导者组成的骨干队伍，他们在研究设计以及临床和流行病学研究的道德行为方面拥有深入的知识和实践技能。临床和公共卫生科学领域的早期职业研究者，并在范德比尔特大学医学中心指导研究伦理学研究； 2) 通过在范德比尔特大学进行为期五周的研究伦理学实习，建立一支哥斯达黎加研究伦理审查主任骨干队伍，他们具有全面的研究伦理实践知识和方案审查技能、研究伦理审查委员会管理以及研究伦理指导医疗中心； 3) 通过在国家儿童医院举办的为期四天的研究伦理委员会成员课程，增强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) 通过在国家儿童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，以改善他们对新研究人员的教学； 5) 创建、评估和分发关于研究伦理和 RCR 的西班牙语课程材料，这些材料适合中美洲背景，并且可以通过开放访问网站和专业人士进一步开发用于本地、区域和跨国合作研究出版物和演示文稿。这项工作将有助于建立哥斯达黎加的研究伦理教育基础设施和人类参与研究审查的专业知识，从而促进国际公共卫生。