Please note: This is a Sole Source Notification. Specifications include, but are not limited to: Weekly meetings to discuss WWU IRB study materials and activities. Focus on recommendations for study review (e.g., exempt, expedited, convened board) as well as rationales for those recommendations. • Summarize and document rationales. • One or more members of the contractor’s board to act as unaffiliated members of the WWU IRB and make exempt determinations and perform expedited review. • Provide review of greater-than-minimal-risk (GTMR) studies. One or more members of the WWU IRB participate in the contractor meetings as reviewer, secondary reviewer, or observer to further gain professional development. • Participate in WWU convened reviews of GTMR studies, either as presenter, board member or consultant. • Provide status reports at least monthly to document (1) contractor’s activities, and (2) assessment of WWU capabilities. • Provide other guidance and training as required, including development of institution-appropriate Standard Operating Procedures and Policies, guidelines for reviewers, and work instructions that would be tailored to the scope of WWU research.
