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Collaborations in Research: The Common IRB Model

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

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Collaborations in Research: The Common IRB Model

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

  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. 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 & UC Davis

  5. 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 VA Northern California & UC Davis

  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

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