The conduct of research that involves human subjects currently takes place in an extraordinarily challenging environment. Although it is recognized that this research is critical for translation of basic research discoveries into practically meaningful advances in clinical medicine, it also is recognized that such research cannot be pursued without first ensuring the rights, interests, and safety of individuals participating in these studies. The purpose of the proposed plan is to develop, implement, and maintain strategies to optimally ensure protection of individuals participating in human subjects research at Emory University. Specifically, the scope of activities comprising this project will encompass educational and technological initiatives directed at both our Institutional Review Board (IRB) committee members and staff, and our investigators engaged in human subjects research.
The specific aims of the proposed project are: 1) To develop a dynamic and comprehensive new training program for IRB members and staff and investigators that is predicated upon Association for the Accreditation of Human Research Protection Programs standards; 2) To create a Human Subjects Research Best Practices Manual to be utilized by Emory IRB members and staff, and investigators; 3) To facilitate the most rigorous and comprehensive review of issues and protocols during IRB meetings through incorporation of teleconferencing capabilities; and 4) To enhance infrastructure support for IRB proposal submission, renewal, and tracking.
These aims will be accomplished through development of a comprehensive """"""""Best Practices"""""""" manual, as well as implementation of technologies to facilitate routine application of these best practices. Additionally, the documents and technologies developed and implemented through this project will be integrated into the ongoing activities of our investigators and IRB members and staff, so as to realize durable benefits from these initiatives.
