Collaborations in Research: The Common IRB Model Eric C. Mah IRB Director University of California Davis Secretarys Advisory Committee.

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The Problem A bureaucratic, regulatory obstacle of double IRB review at local VA & developing HRPP at prominent, neighboring childrens 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

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<p>Collaborations in Research: The Common IRB Model Eric C. Mah IRB Director University of California Davis Secretarys Advisory Committee on Human Research Protections October 19, 2010 UC DAVIS UNIVERSITY OF CALIFORNIA The Problem A bureaucratic, regulatory obstacle of double IRB review at local VA &amp; developing HRPP at prominent, neighboring childrens 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 VA Northern California &amp; 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 VA Northern California &amp; 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 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 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 &amp; Shriners, building regional capacity 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 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</p>

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