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VU-Mozambique Collaborative Research Ethics Education Program

自由大学-莫桑比克合作研究伦理教育项目

基本信息

批准号：
9207117
负责人：
ELIZABETH HEITMAN
金额：
$ 23.81万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-02 至 2018-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9207117
关键词：
AIDS/HIV problem Academic Medical Centers Address Administrator Africa Africa South of the Sahara African Bioethics Biomedical Research Chronic Disease Clinical Research Clinical Trials Collaborations Committee Members Communicable Diseases Country Decentralization Development Diabetes Mellitus Education Educational Activities Educational Curriculum Educational process of instructing Epidemic Ethical Review Ethics European Extramural Activities Faculty Fostering Friends Funding Generations Guidelines HIV Health Health Professional Health system Healthcare Heart Diseases Human Institutes Institution Institutionalization Instruction International International AIDS Investments Joints Knowledge Leadership Malaria Malignant Neoplasms Maps Master of Public Health Medical Medical Research Mentors Mozambique Nongovernmental Organizations Participant Policies Portuguese Process Program Development Protocols documentation Province Public Health Publishing Research Research Design Research Ethics Research Ethics Committees Research Infrastructure Research Methodology Research Personnel Research Proposals Research Training Rest Role Series Societies Standardization Strategic Planning System Traineeship Training Training Activity Tuberculosis United States National Institutes of Health burden of illness career curriculum enhancement design epidemiology study experience falls global health human subject protection knowledge base learning materials programs public health relevance research and development response responsible research conduct scale up science education science teacher skills student training

项目摘要

DESCRIPTION (provided by applicant): The need to address the continued disproportionate burden of disease in Sub-Saharan Africa, resulting from epidemics of HIV/AIDS, tuberculosis, and malaria, as well as increasing rates of such chronic diseases as diabetes, heart disease, and cancer, has dramatically expanded the role for medical research with human participants in the region, and with it the need for thorough and effective ethics review. Lusophone countries fall far behind the rest of Africa, with only one fully operational REC in Portuguese-speaking countries: the Mozambique National Bioethics Committee. The increasing number of research proposals in Mozambique has become an issue of concern for the National Bioethics Committee, to the point that it recently established guidelines for the development of regional and institutional research ethics committees (RECs) to handle the growing influx of proposals. Despite advances in the national infrastructure for the review of human participant research, only a small number of professionals have the knowledge and skills necessary to apply standardized ethical concepts to the research proposals submitted for review. As such, there is significant need for capacity building in the review of human participant research as well as increasing the numbers of qualified investigators who can apply international standards in ethics to their study protocols and who can provide leadership for Mozambique in sustaining a culture for the ethical conduct of research. The specific aims of this study are to 1) create a cadre of Mozambican leaders in biomedical research with in- depth knowledge and practical skills in both research design and the responsible conduct of research (RCR), through tailored masters programs for early-career investigators and mentored research in research ethics at VUMC; 2) enhance the knowledge and practical skills of Mozambican REC members and biomedical science educators in research ethics and RCR; and 3) create, evaluate, and distribute curricular materials on research ethics and responsible conduct of research tailored to Portuguese speakers in Sub-Saharan Africa. A team of experienced research ethics educators from VUMC, UEM, and the National Bioethics Committee seeks to create the Collaborative Research Ethics Education (Forma�ao Colaborativa na Et�ca em Pesquisa, FoCEP) program. We propose a series of interrelated educational activities aimed at building capacity for ethical design, review and conduct of biomedical research in Mozambique. These activities will 1) train Mozambican researchers and research administrators in the design, review, and conduct of biomedical research that meets the highest ethical and scientific standards; 2) strengthen the development and institutionalization of a system for ethical review in Mozambique's biomedical research institutions, 3) enhance the knowledge of standards and approaches to research ethics among biomedical science educators in Mozambique's academic research institutions, and 4) create an annual course and comprehensive curricular materials on research integrity and research with human participants for African investigators and trainees.

描述（由申请人提供）：由于艾滋病毒/艾滋病、结核病和疟疾的流行以及糖尿病、心脏病和癌症等慢性疾病的发病率不断上升，撒哈拉以南非洲地区的疾病负担继续不成比例，因此需要解决这一问题，这大大扩大了该地区有人类参与者的医学研究的作用，同时也需要进行彻底和有效的伦理审查。葡语国家远远落后于非洲其他国家，葡语国家只有一个全面运作的REC：莫桑比克国家生物伦理委员会。莫桑比克越来越多的研究提案已经成为国家生物伦理委员会关注的一个问题，以至于该委员会最近制定了发展区域和机构研究伦理委员会（RECs）的指导方针，以处理不断涌入的提案。尽管在审查人类参与者研究的国家基础设施方面取得了进展，但只有少数专业人员具备将标准化伦理概念应用于提交审查的研究提案所必需的知识和技能。因此，非常需要在审查人类参与者研究方面进行能力建设，以及增加合格的研究人员的数量，这些研究人员可以将国际道德标准应用于他们的研究方案，并且可以为莫桑比克在维持研究道德行为的文化方面发挥领导作用。本研究的具体目标是：1)通过为早期职业研究者量身定制的硕士课程和VUMC研究伦理方面的指导研究，培养莫桑比克生物医学研究领域的领导干部，他们在研究设计和负责任的研究行为（RCR）方面具有深入的知识和实践技能；2)提高莫桑比克REC成员和生物医学科学教育者在研究伦理和RCR方面的知识和实践技能；3)为撒哈拉以南非洲的葡萄牙语使用者创建、评估和分发有关研究伦理和负责任研究行为的课程材料。一个由VUMC、UEM和国家生物伦理委员会经验丰富的研究伦理教育者组成的团队寻求创建合作研究伦理教育（Forma - ao cooperativa na Et - ca em Pesquisa, FoCEP）项目。我们建议开展一系列相互关联的教育活动，旨在建设莫桑比克生物医学研究的道德设计、审查和开展能力。这些活动将1)培训莫桑比克的研究人员和研究管理人员设计、审查和开展符合最高伦理和科学标准的生物医学研究；2)加强莫桑比克生物医学研究机构伦理审查系统的发展和制度化，3)提高莫桑比克学术研究机构生物医学科学教育工作者对研究伦理标准和方法的知识，4)为非洲研究人员和学员创建关于研究诚信和人类参与研究的年度课程和综合课程材料。