Building Local Capacities in Ethics Training and IRB Review in Guatemala

描述(申请人提供)：本申请是对PAR-13-027国际研究道德教育和课程发展奖的回应。拟议的项目建立在宾夕法尼亚大学(宾夕法尼亚大学)与两所危地马拉大学之间现有的生物医学研究能力建设和培训关系的基础上，这两所大学是危地马拉最好的公立大学圣卡洛斯大学(USAC)和旧金山马罗昆大学(UFM)。我们的目标是通过为研究人员和研究评审者创造研究伦理和负责任的研究行为(RCR)方面的学习和实践机会，为这一努力做出实质性贡献。我们的双管齐下的方法将在美国南加州大学医学院的一个新的伦理支持中心建立一个研究伦理知识库，并使机构审查委员会(IRB)的能力专业化并增强其能力。第一项活动包括教师发展和认证计划，旨在建设本国在研究道德和负责任的研究行为(RCR)方面的教学能力。我们还将启动针对危地马拉研究人员、现有和未来的IRB成员、工作人员以及医学和其他研究生的RCR年度培训计划。被培训为RCR认证教师的教职员工将在赠款的第三年之前加入RCR培训活动，并接管项目课程，以在USAC创建一个自给自足的教育计划。同时，我们将加强USAC和UFM的IRBs的能力，以预期和促进这些机构的教职员工和研究生的研究人数不断增加。我们将寻找在IRB管理方面寻求专业职业的候选人，在危地马拉提供英语和基本RCR培训，然后在宾夕法尼亚大学人类研究保护计划进行为期6个月的奖学金培训，其中包括医学英语的特殊培训，然后在他们返回危地马拉后在IRB进行实地实践。该项目的目标是：1)培训RCR和RCR的教职员工干部 能够在USAC和UFM建立可持续的研究伦理教育和培训计划的研究伦理专题、课程设计、教学和评估~2)开发和举办一系列关于RCR和研究伦理专题的年度讲习班，以提高USAC和UFM教职员工、研究生、教职员工和IRB成员的伦理技能，同时为寻求获得这些学科领域培训者资格的危地马拉教职员工提供实践教学经验~3)培训危地马拉专业人员担任IRBs的行政责任职位，以加强和扩大他们审查、监督和促进USAC和UFM研究的能力。

DESCRIPTION (provided by applicant): This application is in response to PAR-13-027, International Research Ethics Education and Curriculum Development Award. The proposed project builds on an existing relationship in biomedical research capacity- building and training between the University of Pennsylvania (Penn) and two Guatemalan universities, the Universidad de San Carlos de Guatemala (USAC), the country's premier public university, and the Universidad Francisco Marroquin (UFM). We aim to contribute substantively to this endeavor by creating learning and practice opportunities in research ethics and the responsible conduct of research (RCR) for researchers as well as reviewers of research. Based in a new Ethics Support Center in the medical school at USAC, our two-pronged approach will develop a research ethics knowledge base in the Universities, and professionalize and enhance Institutional Review Board (IRB) capacities. The first activity comprises a faculty development and certification program designed to build in-country teaching capacity in research ethics and responsible conduct of research (RCR) we will also initiate an annual RCR training program for Guatemalan researchers, current and prospective IRB members, staff, and medical and other graduate students. Faculty trained as certified RCR teachers will join in the RCR training activities by year 3 of the grant, and take over the project courses to create a self-sustaining educational program at USAC. In parallel, we will enhance the capacity of IRBs at USAC and UFM in anticipation of and to facilitate the growing body of research expected of faculty and graduate students at these institutions. We will identify candidates who seek professional careers in IRB administration, provide English language and basic RCR training in Guatemala, followed by a 6-month fellowship training at the Human Research Protections Program at Penn that includes special training in medical English, followed by a field practicum at an IRB upon their return to Guatemala. The aims of this project are to: 1) train a cadre of faculty in RCR and research ethics topics, curriculum design, teaching, and evaluation who are able to build sustainable research ethics education and training programs at USAC and UFM~ 2) develop and present a series of annual workshops on RCR and research ethics topics that will enhance ethics skills of USAC and UFM faculty, graduate students, staff, and IRB members who are engaged in research while providing hands-on teaching experience for Guatemalan faculty seeking certification as trainers in these subject areas~ and 3) train a staff of Guatemalan professionals to assume positions of administrative responsibility for IRBs in order to enhance and expand their capacities to review, monitor, and facilitate research at USAC and UFM.