The University of Washington is using 2002-2003 HSREP funding to design and deploy a web-based system (UWISE) for preparing and managing IRB applications. We now propose to strengthen the human research protection program by broadening our educational and compliance efforts with collaborating research institutions, regulatory committees, and potential research subjects. The specific objectives are to: 1. Integrate regulatory committees and activities, both inside and outside the UW, into the web-based system for managing the protection of human subjects in research. These include radiation safety, financial interest reviews, and post-approval monitoring. 2. Create web-based mechanisms for extemal research collaborators and subject groups to participate in the review and monitoring of research involving human subjects. This will entail not only support for web-based IRB meetings, but also the development of specific tools for off-campus research partners and for groups whose leadership must be part of the decision-making process. 3. Enhance educational programs for external research partners, students, and IRBs at collaborating institutions. We will partner with the Northwest Association for Biomedical Research (NWABR) to develop IRB member training for collaborating regional institutions and Public Responsibility in Medicine and Research (PRIM&R) to support IRB training for international collaborators from resource-poor countries. 4. Develop and implement an educational program on participation in clinical and non-clinical research for potential research subjects. We will collaborate with the Northwest Association for Biomedical Research (NWABR) create curriculum and a speaker's registry dedicated to providing community groups with information about research participation, oversight, and integrity. We will also develop a tutorial that will assist potential subjects in understanding the human research protection program, how they may protect themselves, and how they may participate.
