Building Local Capacities in Ethics Training and IRB Review in Guatemala

描述（由申请人提供）：本申请是为了响应PAR-13-027，国际研究伦理教育和课程发展奖。拟议的项目建立在宾夕法尼亚大学和危地马拉两所大学——危地马拉的主要公立大学圣卡洛斯大学（USAC）和弗朗西斯科·马罗昆大学（UFM）——在生物医学研究能力建设和培训方面的现有关系的基础上。我们的目标是通过为研究人员和研究评审人员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。在USAC医学院的一个新的伦理支持中心，我们双管齐下的方法将在大学中建立一个研究伦理知识库，并专业化和提高机构审查委员会（IRB）的能力。第一项活动包括教师发展和认证计划，旨在建立国内研究伦理和负责任的研究行为（RCR）的教学能力。我们还将为危地马拉研究人员、现任和未来的IRB成员、工作人员、医学和其他研究生启动年度RCR培训计划。经过认证的RCR教师培训的教师将在赠款的第三年参加RCR培训活动，并接管项目课程，在USAC创建一个自我维持的教育计划。与此同时，我们将提高USAC和UFM的irb的能力，以预期并促进这些机构对教师和研究生日益增长的研究群体的期望。我们将确定寻求IRB管理专业职业的候选人，在危地马拉提供英语和基本的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进行实地实习。这个项目的目的是：1)培养RCR和

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.