Building Local Capacities in Ethics Training and IRB Review in Guatemala

建立危地马拉当地道德培训和 IRB 审查能力

• 批准号: 8664713
• 负责人: Jon F. Merz
• 金额: $ 20.58万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-29 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8664713
• 关键词: Address; Administrator; Area; Award; Biomedical Research; Certification; Continuing Education; Country; Development; Education; Educational Curriculum; Educational process of instructing; Educational workshop; English Language; Ensure; Environment; Epidemiology; Ethics; Evaluation; Evolution; Faculty; Fellowship; Funding; Goals; Grant; Guatemala; Guatemalan; Health; Hospitals; Hour; Human; Human Subject Research; Institution; Institutional Review Boards; International; Knowledge; Learning; Medical; Medical Staff; Mentors; Monitor; Pennsylvania; Physicians; Positioning Attribute; Program Development; Research; Research Ethics; Research Personnel; Research Training; Secure; Series; System; Teacher Professional Development; Training; Training Activity; Training Programs; United States National Institutes of Health; Universities; Work; base; career; case-based; clinical epidemiology; cohort; design; experience; graduate student; human subject protection; instructor; interest; knowledge base; medical schools; meetings; member; programs; prospective; public health relevance; residence; response; responsible research conduct; skills; symposium; teacher

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.

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开发奖。拟议的项目建立在宾夕法尼亚大学 (Penn) 与危地马拉两所大学——危地马拉首屈一指的公立大学危地马拉圣卡洛斯大学 (USAC) 和弗朗西斯科马罗坎大学 (UFM) 之间在生物医学研究能力建设和培训方面现有的关系的基础上。我们的目标是为研究人员和研究审稿人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。我们以 USAC 医学院的新伦理支持中心为基础，采取双管齐下的方法，在大学中建立研究伦理知识库，并专业化和增强机构审查委员会 (IRB) 的能力。第一项活动包括教师发展和认证计划，旨在建设研究伦理和负责任的研究行为（RCR）方面的国内教学能力，我们还将为危地马拉研究人员、现任和未来的 IRB 成员、工作人员以及医学和其他研究生启动年度 RCR 培训计划。接受过 RCR 认证教师培训的教师将在拨款的第 3 年加入 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，我们将增强 USAC 和 UFM 的 IRB 的能力，以预测和促进这些机构的教师和研究生所期望的不断增长的研究。我们将确定在 IRB 管理领域寻求职业生涯的候选人，在危地马拉提供英语语言和基本 RCR 培训，然后在宾夕法尼亚大学人类研究保护计划接受为期 6 个月的奖学金培训，其中包括医学英语特殊培训，然后返回危地马拉后在 IRB 进行现场实习。该项目的目标是： 1) 培养一支 RCR 的骨干教师队伍 能够在 USAC 和 UFM 建立可持续研究伦理教育和培训计划的研究伦理主题、课程设计、教学和评估人员~ 2) 制定并举办一系列关于 RCR 和研究伦理主题的年度研讨会，以提高从事研究的 USAC 和 UFM 教师、研究生、工作人员和 IRB 成员的伦理技能，同时为寻求培训师认证的危地马拉教师提供实践教学经验 3) 培训危地马拉专业人员担任 IRB 的行政职务，以增强和扩大他们审查、监督和促进 USAC 和 UFM 研究的能力。