The long-term objective of this proposed project is to improve the protection of research subjects who volunteer to participate in research conducted by the Kaiser Permanente Medical Care Program (Kaiser Permanente). In order to accomplish this objective, the project aims to support the development and dissemination of four initiatives which build upon and expand existing capacities in Kaiser Permanente (KP).The proposed initiatives are: 1. An interactive CD-ROM for investigators on informed consent, which will combine didactic information reflecting applicable Federal regulations and KP policies on obtaining informed consent from research subjects with video clips demonstrating effective consent interactions between an investigator and a potential research subject. This initiative will include the development of a companion manual that will include a transcript of the CD-ROM, guidance on writing a consent form, sample consent forms, and other pertinent information, such as consenting non-English speakers and members of vulnerable populations. 2. A reference manual for members of KP IRBs on informed consent that summarizes all relevant regulations and provides tools to support primary reviewers and other IRB members in reviewing and monitoring informed consent. Training based on this manual will be mandated for all KP IRB members. 3. Web-based training module on the Conduct of Clinical Trials, which will be based on the recently published handbook developed by KFRI, """"""""Conducting Clinical Trials in Kaiser Permanente: A Handbook for Clinical Research Investigators and Coordinators. This training module will become a component of KP's larger training program on the responsible conduct of research. 4. Dissemination of the Trial Information Management System (TIMS) database to certain clinical trial sites in KP. The custom TIMS database and hardware are being donated by KP. This proposed project will also support the communication and dissemination these four initiatives.
