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

摘要：莫桑比克政府预测未来十年研究活动的增长和 多个国际机构强调，继续需要在研究伦理方面继续进行能力建设 未来。随着基础、转化、临床和公共卫生研究体系的建立， 研究伦理方面的并行能力发展将对解决关键的地方相关研究至关重要 以合乎道德的方式提出问题。需要注意的四个最明显的领域是：1) 研究生和专业生研究人员及其论文的伦理教育、审查和监督 研究项目；2)利用生物标本和临床研究的迅速增长 流行病学数据，包括生物库和国家数据仓库的开发；3)研究 预防和治疗传染病和非传染性疾病；以及4)国际协作 需要对可能不同的监管机构的权威进行双重审查和达成一致的研究 伙伴国的要求。 由来自UEM、UTSW和VIGH的经验丰富的研究伦理教育者组成的团队，与 国家健康生物伦理委员会(CNBS)寻求更新Formação Colborativa em etíca NA Pesquisa，FOCEP(合作研究道德教育--莫桑比克)。我们提出了一系列 相互关联的教育目标和活动，旨在建设道德设计、审查和实施的能力 莫桑比克的生物医学研究。本研究的具体目的是：1)扩大莫桑比克干部队伍 在生物医学研究方面具有深入的知识和实践技能的领导者，在研究设计和 通过定制的公共卫生硕士课程和硕士水平进行临床和流行病学研究的道德行为 加强UEM的课程；2)加强莫桑比克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和研究诚信方面；以及3)进一步创建， 评估和分发有关研究道德和负责任的研究行为的课程材料 为讲葡萄牙语的非洲人量身定做。 在FoCEP活动的第一阶段进行了5年的协作参与后，计划实施团队 独一无二地熟悉该国的挑战，并处于有利地位，可以进一步发展莫桑比克的 研究伦理能力、研究方案的伦理审查以及提供研究伦理和 对国家下一代卫生科研人员进行诚信教育。该团队拥有全面的 研究道德知识和负责任的研究行为；健康科学教育技能； 和流利的葡萄牙语，再加上它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，使其非常适合进行 这个更新计划是在这里提出的。

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.