RTI's mission is """"""""to improve the human condition through objective, innovative, multidisciplinary research, development and technical services, setting the standard for scientific and professional excellence."""""""" To fulfill our mission, we must ensure that our research meets the highest ethical standards and that the rights and safety of all of our study participants are protected. RTI has an established human subjects protection program that enjoys the support of upper management and the respect of researchers. This grant will allow us to strengthen our program to keep pace with new issues in the changing human subjects environment. Our grant application consists of three complimentary components: (1) developing a module on human subjects protection to be used for a university-based training in responsible conduct of research, (2) hosting a symposium on human subjects and privacy issues relevant to international research, and (3) the transition of our existing IRB management information system to the intranet to allow for electronic submission of protocols and amendments, automatic generation of approval notices, tracking logs for amendments and adverse events, and ready access by investigators to standard on-line forms. It is important that not only researchers, but also students in various research disciplines, be trained in the ethics and practices of responsible research. The responsible conduct of research (RCR) training module we propose will include information about methods for protecting human subjects that are ethically sound and satisfy the federal regulations. This will be part of a comprehensive RCR curriculum focused on social research and will be developed in collaboration with a consortium of local universities. The international symposium will bring together speakers and attendees from the U.S. and abroad to discuss human subjects and privacy issues relevant to research conducted in other countries. Finally, our computerized IRB management information system (MIS) has been evolving over several years. During the first year of our HSREP grant, we began to augment this system. During the second year, we plan to continue to streamline the system by adapting the MIS, and the IRB forms associated with it, for web-based application. This will significantly streamline our IRB operations, and help our researchers navigate the system efficiently, while still assuring that we operate within all applicable regulations. This will allow the IRB staff to devote more time interacting directly with researchers and giving guidance on specific human subjects issues.
| Hubal, Robert C; Day, Ruth S (2006) Informed consent procedures: an experimental test using a virtual character in a dialog systems training application. J Biomed Inform 39:532-40 |
