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

• 批准号: 8845448
• 负责人: ELIZABETH HEITMAN
• 金额: $ 24.17万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 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/8845448
• 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; Development; Diabetes Mellitus; Education; Educational Activities; Educational Curriculum; Educational process of instructing; Epidemic; Epidemiologic Studies; Ethical Review; Ethics; European; Faculty; Fostering; Friends; Funding; Generations; Guidelines; HIV; Health; Health Professional; Health system; Healthcare; Heart Diseases; Human; Institutes; Institution; Institutionalization; International; International AIDS; Investments; Joints; Knowledge; Leadership; Malaria; Malignant Neoplasms; Maps; Master of Public Health; Medical; Medical Research; Mentors; Mozambique; Participant; Policy Research; Process; Protocols documentation; Province; Psyche structure; Public Health; Publishing; Qualifying; Research; Research Design; Research Ethics; Research Ethics Committees; Research Infrastructure; Research Methodology; Research Personnel; Research Proposals; Research Training; Rest; Role; Science; Series; Societies; Strategic Planning; Students; System; Traineeship; Training; Training Activity; Tuberculosis; United States National Institutes of Health; burden of illness; career; design; experience; falls; global health; human subject protection; knowledge base; meetings; programs; research and development; response; responsible research conduct; scale up; science education; skills

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(申请人提供)：需要解决撒哈拉以南非洲地区由于艾滋病毒/艾滋病、结核病和疟疾的流行而造成的持续不成比例的疾病负担，以及糖尿病、心脏病和癌症等慢性病发病率的增加，这极大地扩大了该地区人类参与者参与的医学研究的作用，以及对彻底和有效的伦理审查的需要。葡语国家远远落后于非洲其他国家，在葡语国家中只有一个全面运作的区域经济共同体：莫桑比克国家生物伦理委员会。莫桑比克越来越多的研究建议已成为国家生物伦理委员会关注的问题，以至于该委员会最近为发展地区和机构研究伦理委员会(RECs)制定了指导方针，以处理日益涌入的建议。尽管在审查人类参与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的伦理概念应用于提交审查的研究提案所需的知识和技能。因此，在审查人类参与研究方面极有必要进行能力建设，并需要增加合格研究人员的数量，使他们能够将国际道德标准应用于其研究方案，并能够领导莫桑比克维持一种以道德方式进行研究的文化。这项研究的具体目的是：1)培养一支在研究设计和负责任的研究行为(RCR)方面具有深入知识和实践技能的莫桑比克生物医学研究领导者队伍，通过VUMC为职业早期研究人员量身定做的硕士课程和研究伦理指导研究；2)提高莫桑比克REC成员和生物医学教育工作者在研究伦理和RCR方面的知识和实践技能；以及3)为撒哈拉以南非洲讲葡萄牙语的人制作、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。来自VUMC、UEM和国家生物伦理委员会的经验丰富的研究伦理教育者团队寻求创建合作研究伦理教育(Forma？ao Colborativa na etéca em Pesquisa，FoCEP)计划。我们提出了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伦理设计、审查和开展的能力。这些活动将1)培训莫桑比克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制度的发展和制度化；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了解；4)为非洲研究人员和受训人员编写关于研究诚信和有人类参与的研究的年度课程和综合课程材料。