Collaborations in Research:The Common IRB Model
Eric C. MahIRB Director
University of California – [email protected]
Secretary’s Advisory Committee on Human Research Protections October 19, 2010
UC DAVISUNIVERSITY OF CALIFORNIA
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
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
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
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 & 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
