Commercial IRB Model

1
Commercial IRB Model

• Workshop on Comparing Institutional Review Board
  (IRB) Models for Multi-site Pediatric Studies

Stephen Rosenfeld, M.D., M.B.A. Western
Institutional Review Board
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Commercial IRBs

• Fee-for-service is a financing model to support
  IRB operations
• The role of the company is to provide the Board
  members with the materials and appropriate
  environment so that they can focus on ethical
  determinations
• Allows full recognition of all costs of Board
  support
• Service is review, not approval

3
Resources

• Context of variability, volume, complexity
• Not directly comparable to Institutional or
  domain-specific IRBs

Staff 300 Board members 120 Panels 13 Protocols 5,
500 Investigators 9,000
WIRB
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Pediatric Expertise

• Staff physicians/Board members with pediatric
  expertise
• Extensive use of consultants

5
Metrics

• Review time
• Major revisions
• Stipulations
• Cost
• What do we really want to measure?

6
IRB Interaction

• Local, Central, WIRB
• Oversight scope may be defined by contract
• WIRB may also be central IRB
• Joint IRB agreements