E-enhanced Collaborative Ethics Committee Review of Research Protocols

描述(由申请者提供)：联合研究生院建议使用商业上可用的电子协作工具套件来开发一个可定制和可扩展的在线平台，以促进美国和海外伦理委员会对研究方案的联合审查。这一在线平台还将为寻求国际研究伦理额外培训的研究人员和伦理委员会成员提供教育资源，包括美国和国际关于涉及人类受试者的研究的法规和指导方针，以及在发展中国家背景下设计、审查和开展研究的基本伦理原则。这一在线工具旨在满足美国和外国伦理委员会的教育和交流需求，这是通过仔细审查格鲁吉亚第比利斯州立医科大学(中低收入国家)研究人员十年来进行的研究而确定的。这次审查将侧重于确定阻碍及时审查这些议定书的行政、科学和跨文化障碍，并将由一个由来自美国和乔治亚共和国的10名专家组成的指导委员会进行。一旦开发了电子平台，指导委员会将通过开展一系列在线模拟方案审查工作，评估其在最大限度地减少有效审查人类受试者研究的障碍方面的有效性。这项评估的结果将用于在线平台设计的进一步改进，以及确定美国和外国道德委员会成员的继续教育需求。旨在满足这些教育需求的一系列网络研讨会和其他资源将与议定书审查工具一起打包成可通过在线平台获得的独立能力建设模块。虽然这一在线平台将根据对在乔治亚共和国进行的研究的分析进行开发和试点，但在设计传播工具和教育模块时，将着眼于它们对发展中世界人类主题研究的普遍适用性。然后，该平台将提供给所有格鲁吉亚IRBs和工作人员，以及Fogarty赞助的其他有兴趣使用传播工具或调整教育材料以适应其自身培训需要的计划。 与公共健康相关：NIH资助的在海外进行的临床研究必须接受美国和那些正在进行试验的国家的研究伦理委员会的低效和耗时的审查。沟通和教育障碍可能使美国和外国委员会很难(如果不是不可能)调和分歧并批准研究方案，导致至关重要的临床和公共卫生研究被推迟甚至取消。该项目的目标是确定合作审查研究方案的行政、文化和后勤障碍，并开发和试点一个在线交流和教育平台，该平台可被美国和海外的伦理委员会广泛使用，以更有效地审查共享研究，并提高在海外进行的临床和公共卫生研究的及时性和成本效益。

DESCRIPTION (provided by applicant): Union Graduate College proposes to use a commercially-available suite of electronic collaboration tools to develop a customizable and scalable online platform to facilitate joint review of research protocols by ethics committees in the US and overseas. This online platform will also serve as an educational resource for researchers and ethics committee members who seek additional training in international research ethics, covering such topics as US and international regulations and guidelines for research involving human subjects, and basic ethical principles in the design, review and conduct of research in a developing country context. This online tool will be designed to address the educational and communication needs of US and foreign ethics committees as identified through careful review of ten years of research studies conducted by researchers at Tbilisi State Medical University in the Republic of Georgia (a low-middle income country). This review will focus on identifying administrative, scientific and cross-cultural barriers that prevented the timely review of those protocols, and will be conducted by a Steering Committee made of up ten experts from the US and the Republic of Georgia. Once the electronic platform is developed, the Steering Committee will evaluate its effectiveness in minimizing barriers to efficient review of human subjects research by conducting a series of online mock protocol review exercises. The results of this evaluation will be used to make additional improvements in the design of the online platform, as well as to identify continuing educational needs for US and foreign ethics committee members. A series of webinars and other resources designed to address these educational needs will be packaged, along with the protocol review tools, into free-standing capacity-building modules available via the online platform. Although this online platform will be developed and piloted according an analysis of research conducted in the Republic of Georgia, the communication tools and educational modules will be designed with an eye to their general applicability to human subjects research in the developing world. The platform will then be made available to all Georgian IRBs and staff, as well as other Fogarty-sponsored programs interested in using the communication tools or adapting the educational materials to fit their own training needs. PUBLIC HEALTH RELEVANCE: NIH-funded clinical studies that are conducted overseas must undergo inefficient and time- consuming review by research ethics committees in both the US and those countries where the trials are taking place. Communication and educational barriers can make it difficult, if not impossible, for US and foreign committees to reconcile their differences and approve research protocols, resulting in critically important clinical and public health studies being delayed or even cancelled. The goal of this project is to identify the administrative, cultural and logistical barriers to collaborative review of research protocols, and to develop and pilot an online communication and education platform that can be used widely by ethics committees in the US and abroad to engage in more efficient review of shared research and to improving the timeliness and cost- effectiveness of clinical and public health studies conducted overseas.