1. Collaborations in Research: The Common IRB Model Eric C. Mah IRB Director University of California – Davis ecmah@ucdavis.edu Secretary’s Advisory Committee on Human Research Protections October 19, 2010

2. UC DAVIS UNIVERSITY OF CALIFORNIA

3. The Problem A bureaucratic, regulatory obstacle of double IRB review at local VA & developing HRPP at prominent, neighboring children’s hospital VA Northern California Health Care System –Local IRB with limited resources –Duplicative review for UC Davis faculty with joint appointments Northern California Shriners Hospitals for Children –Lack capacity, expertise for a local IRB –Limited resources available for commercial IRB review

4. VA Northern California & UC Davis Opportunities New relationship requires trust, communication Eliminate a double IRB review Save researcher, institutional resources Faster site initiation Streamline IRB review process Risks/Threats Unfamiliar VA structure, policies and bureaucracy Additional administrative burden on UC Davis Increased administrative costs for UC Davis

5. VA Northern California & UC Davis Opportunities Expand research, collaboration in pediatrics Support a neighbor institution Save researcher, institutional resources Faster site initiation Risks/Threats Shriners lacked a clear research compliance program –No COI review, etc. Some researchers unaffiliated with UC Davis UC Davis possibly exposed to significant liability

6. UC Davis’ Pathway to Success VA –Established new workflows and business processes to adapt to local policies, procedures 200+ studies avoid double IRB review –Significantly increased VA engaged research Increase in CTSC-VA engaged studies from 5 to 39+ Increased VA research funding to $32 M –Offered cutting edge research to VA patients –Increased accrual to oncology trials for UC Davis NCI-designated cancer center –Clinical research resources that would not otherwise be available for both institutions

7. UC Davis’ Pathway to Success Shriners Hospital –Education, conceptualization of a human research protection program –Established FWA, MOU with UC Davis UC Davis also performs COIC review, as needed –30+ studies reviewed on behalf of Shriners The UC Davis CTSC played a pivotal role in partnering with VA & Shriners, building regional capacity

8. UC Davis Results Increased the number of available trials between the institutions All stakeholders needs addressed through ongoing communication, open channels –Designated VA-UC Davis liaison Efficiencies identified, resources preserved –Especially true for VA, Shriners, and UC Davis researchers The rights and welfare of research subjects in no way compromised

9. UC Davis - Future Ongoing, shared commitment to human subjects protection Identify other institutions and entities for collaboration, expansion Creativity, open-mindedness, and willing to trust-- ensures future successes