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.
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.