Collaborative Research Ethics Education-Mozambique (Formaçao Colaborativa em Etica na Pesquisa, FoCEP)

翻译后摘要：在研究活动的增长，预计未来十年由莫桑比克政府和 多个国际机构强调，继续需要在研究伦理方面进行能力建设， 未来随着基础、转化、临床和公共卫生研究体系的建立， 在研究伦理方面的平行能力发展对于处理与当地相关的重要研究至关重要 以符合道德的方式提问。需要注意的四个最明显的领域是： 研究生和专业学生研究人员及其论文的道德教育、审查和监督 研究项目; 2）使用生物标本和临床研究的蓬勃发展， 流行病学数据，包括建立生物库和国家数据库; 3） 预防和治疗传染病和非传染性疾病; 4）国际合作 需要双重审查并就潜在不同监管机构的权威达成一致的研究 伙伴国的要求。 来自UEM，UTSW和VIGH的经验丰富的研究伦理教育工作者团队，与 国家卫生生物伦理委员会（CNBS）寻求更新 Pesquisa，FoCEP（莫桑比克合作研究伦理教育）。我们提出了一系列 相关的教育目标和活动，旨在培养道德设计、审查和实施的能力， 在莫桑比克进行生物医学研究。这项研究的具体目标是：1）扩大莫桑比克的干部队伍， 生物医学研究的领导者，在研究设计和 通过量身定制的MPH计划和硕士水平的临床和流行病学研究的道德行为 UEM的课程改进; 2）提高莫桑比克REC的知识和实践技能 成员和研究教育工作者在研究伦理，RCR，和研究诚信;和3）进一步创建， 评估和分发关于研究道德和负责任的研究行为的课程材料 专为讲葡萄牙语的非洲人量身打造 经过5年的合作参与第一阶段的FoCEP活动，该计划的实施团队 特别熟悉该国的挑战，并有能力进一步发展莫桑比克的 研究伦理、研究方案伦理审查以及提供研究伦理和 对国家下一代卫生研究人员进行诚信教育。该团队拥有全面的 研究伦理知识和负责任的研究行为;健康科学教育技能; 葡萄牙语流利，加上其在国家和机构内部建立的关系， 生物伦理委员会、卫生部和研究型大学使其非常适合实施 在此提出的更新方案。

Abstract: The growth in research activity projected for the next decade by the Mozambican government and multiple international agencies highlights the continued need for capacity building in research ethics well into the future. With the groundwork laid for systems of basic, translational, clinical and public health research, parallel capacity development in research ethics will be essential to address critical locally relevant research questions in an ethically-consistent way. The four most evident areas in which attention is needed are: 1) ethics education, review and oversight of graduate and professional student researchers and their thesis research projects; 2) the burgeoning growth of research using biological specimens and clinical and epidemiologic data, including the development of biobanks and a national data warehouse; 3) research on the prevention and treatment of infectious and non-communicable diseases; and 4) international collaborative research that requires dual review and agreement on the authority of the potentially different regulatory requirements of partner countries. A team of experienced research ethics educators from UEM, UTSW, and VIGH, in collaboration with the National Bioethics Committee for Health (CNBS) seeks to renew the Formação Colaborativa em Etíca na Pesquisa, FoCEP (Collaborative Research Ethics Education-Mozambique). We propose a series of interrelated educational aims and activities intended to build capacity for ethical design, review, and conduct of biomedical research in Mozambique. The specific aims of this study are to 1) expand the cadre of Mozambican 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 a tailored MPH program and masters-level curriculum enhancements at UEM; 2) enhance the knowledge and practical skills of Mozambican REC members and research educators in research ethics, RCR, and research integrity; and 3) further create, evaluate, and distribute curricular materials on research ethics and the responsible conduct of research tailored to Portuguese speaking Africa. After 5 years of collaborative engagement in phase one of FoCEP activities, the program implementation team is uniquely familiar with the country's challenges and are well positioned to further develop Mozambique's capacity in research ethics, ethical review of research protocols, and the provision of research ethics and integrity education to the country's next generation of health researchers. The team has comprehensive knowledge of research ethics and the responsible conduct of research; skill in health sciences education; and fluency in Portuguese that, together with its established relationships within the National and Institutional Bioethics Committees, Ministry of Health, and research-oriented universities, make it well suited to carry out this renewal program proposed here.