How local IRBs view central IRBs in the US

Area of Science:

• Medical Ethics
• Clinical Research Administration
• Regulatory Science

Background:

• Centralized Institutional Review Board (cIRB) reviews are increasing in the US and globally.
• The operational models and effectiveness of cIRBs remain unclear.
• Existing literature lacks comprehensive comparisons between local and centralized IRB systems.

Purpose of the Study:

• To explore the perceptions and experiences of IRB professionals regarding local and centralized IRB models.
• To identify the perceived advantages and disadvantages of both local and centralized IRB reviews.
• To inform future policy discussions on IRB review structures.

Main Methods:

• Qualitative study involving interviews with leaders and members of 34 IRBs.
• Surveyed 60 IRBs from top NIH-funded institutions.
• Response rate of 55% from contacted IRB leaders.

Main Results:

• Interviewees favored local IRBs for their "local knowledge," trust-building, and informal PI engagement.
• Local IRBs fostered a sense of responsibility towards "their own" subjects.
• While some advantages of cIRBs were noted (e.g., streamlining), interviewees expressed wariness regarding their variable quality and potential unintended consequences.
• Discrepancies between IRBs seemed linked to institutional culture and personalities, not solely regulatory intent.

Conclusions:

• The debate on IRB centralization should move beyond a binary choice to explore hybrid models and varying degrees of centralization.
• Critical tradeoffs and uncertainties exist with cIRBs, and they may not be a panacea for all IRB issues.
• Future policy must carefully weigh the benefits of local IRBs against their problems and explore systems that retain local advantages while mitigating disadvantages.