MBARARA UNIVERSITY RESEARCH ETHICS EDUCATION PROGRAM (MUREEP)

摘要 撒哈拉以南非洲的国际研究数量正在增加，很大程度上是因为非洲大陆的 疟疾、艾滋病毒和最近的非传染性疾病等疾病造成了独特的高负担。这个 大陆还面临着埃博拉和寨卡病毒等新出现的全球卫生挑战，所有这些都将需要 测试新药、医疗器械或了解病理生理学。许多研究现在包括 基因检测等复杂研究。国际研究的数量和复杂性的增长 给研究伦理委员会带来了挑战，因为他们中的大多数都没有做好充分的准备来审查 这些复杂的项目。资源有限的设置也呈现出独特的功能，例如在 主要是不识字的研究人群，可能破坏基本原则的父权制社会 例如自主性和保密性。有必要培训REC和研究人员，使他们意识到这些 新的挑战，并设计出如何应对它们的方法。 为了满足这些需求，有必要在撒哈拉以南非洲建立研究伦理培训。我们建议 姆巴拉拉大学研究伦理教育计划(MUREEP)构建多层次研究伦理 乌干达的产能。姆巴拉拉科技大学(MUST)定位独特， 实施所需的培训，以建设其研究人员、导师和REC的研究道德能力，如 以及其他当地机构的信息。我们在凯斯西储大学(CWRU)的合作者， 哈佛大学、马凯雷雷大学和乌干达国家科学技术委员会(UNST) 将把他们在国际和当地研究道德方面的广泛专业知识带给团队。我们建议1) 建立和实施一个可持续的公共卫生硕士学位-研究伦理学学位必须在12名学生中毕业 在授权期内。将公共卫生硕士学位与研究伦理相结合将导致公众 具有广泛的伦理知识，并在就业市场上具有竞争力的健康研究人员。2)提供 短期课程和能力建设活动，将在该区域培训至少525名参与者。 我们提议的短期课程计划将包括关注遗传学研究和生物银行的伦理， 这是该地区第一个必须这样做的地方。3)培养一大批教师和导师，以实现可持续发展 研究乌干达西南部的道德培训，并在以下方面为教师提供培训和支持 研究伦理方面的教学/辅导，以及4)加强REC在必须和其他地方的专业知识 机构。

Summary The volume of international research in sub Saharan Africa is increasing largely because of the continent’s unique high burden of diseases such as malaria, HIV and more recently non-communicable diseases. The continent also faces emerging global health challenges such as Ebola and Zika virus all of which will require testing of new medicines, medical devices or understanding the pathophysiology. Many studies now include complex research such as genetic testing. The growth in volume and complexity of international research presents challenges to research ethics committees because most of them are inadequately prepared to review these complex projects. Resource limited settings also present unique features such as research among predominantly non-literate study populations, patriarchal society which may undermine fundamental principles such as autonomy and confidentiality. There is need to train RECs and researchers to become aware of these new challenges and devise ways of how to deal with them. To meet these needs, it is necessary to establish research ethics training in Sub Saharan Africa. We propose the Mbarara University Research Ethics Education Program (MUREEP) to build multi-level research ethics capacity in Uganda. Mbarara University of Science and Technology (MUST) is uniquely positioned, to implement the training needed to build the research ethics capacity of its investigators, mentors, and REC, as well as those of other local institutions. Our collaborators at Case Western Reserve University (CWRU), Harvard University, Makerere University and Uganda National Council of Science and Technology (UNCST) will bring their extensive expertise in international and local research ethics to the team. We propose to 1) establish and implement a sustainable MPH-Research Ethics degree at MUST that will graduate 12 students over the grant period. Combining a public health master’s degree with research ethics will result in a public health researcher with extensive knowledge in ethics and who will be competitive in the job market. 2) Offer a repertoire of short courses, and capacity building activities that will train at least 525 participants in the region. Our proposed program of short courses will include a focus on the ethics of genetics research and bio-banking, the first of its kind at MUST and in the region. 3) Create a critical mass of teachers and mentors for sustainable research ethics training in southwestern Uganda and provide training and support for faculty in teaching/mentoring in research ethics, and 4) Strengthen the expertise of REC at MUST and other local institutions.