E-enhanced Collaborative Ethics Committee Review of Research Protocols

描述（由申请人提供）：联合研究生院建议使用一套商业化的电子协作工具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。该在线平台还将作为研究人员和伦理委员会成员的教育资源，他们寻求国际研究伦理方面的额外培训，涵盖美国和国际涉及人类受试者的研究法规和指南，以及发展中国家研究设计，审查和实施的基本伦理原则等主题。该在线工具旨在满足美国和外国伦理委员会的教育和沟通需求，这些需求是通过仔细审查第比利斯共和国第比利斯国立医科大学的研究人员进行的十年研究而确定的。格鲁吉亚（中低收入国家）。该审查将侧重于确定阻碍及时审查这些方案的行政、科学和跨文化障碍，并将由来自美国和格鲁吉亚共和国的10名专家组成的指导委员会进行。电子平台开发完成后，指导委员会将进行一系列网上模拟方案审查工作，评估其在尽量减少有效审查人类受试者研究的障碍方面的成效。评估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伦理委员会成员的继续教育需求。一系列旨在满足这些教育需求的网络研讨会和其他资源将与议定书审查工具一起沿着，通过在线平台提供独立的能力建设模块。虽然这一在线平台将根据对在格鲁吉亚共和国进行的研究进行的分析来开发和试用，但在设计通信工具和教育模块时，将着眼于它们对发展中国家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IRB和工作人员，以及其他有兴趣使用通信工具或调整教育材料以适应自己的培训需求的福格蒂赞助的项目。 公共卫生相关性：在海外进行的NIH资助的临床研究必须经过美国和试验所在国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难以（如果不是不可能的话）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研究方案合作审查的行政、文化和后勤障碍，并开发和试点一个在线交流和教育平台，供美国和国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.