Comparing IRB Models for Multisite Pediatric Studies

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Comparing IRB Models for Multisite Pediatric
Studies
Debbie Gipson, MD, MSPH Multicenter Studies
PI Associate Director, Child Health Core NC
Translational and Clinical Science
Institute Chair of T2 Workgroup Child Health
Oversight Committee debbie_gipson_at_med.unc.edu Chap
el Hill, NC
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Rationale, Policy and Process

• Rationale facilitate multisite research to
  improve the health of the children of our
  country.
• Inherent in this goal is the
• ethical and safe conduct of research
• efficient scientific advance by shortening the
  timeline to completion of studies
• focus application of trial allocated resources

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Policy is Permissive
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Process

• Scope (qualifying studies phase I single or
  few sites)
• Seating the board ped expertise w/ use of
  content expert consults
• Reciprocal IRB unlikely to work in large and
  variable network like CTSA
• Canary model (rotationg irb) reasonable model but
  continues to place a large administrative burden
  on every site for local application preparation.
• Central/Independent IRB model quality review
  diminish duplicative effort