When IRBs Say No to Participating in Research about Single IRBs

Area of Science:

• Health Services Research
• Regulatory Science
• Clinical Trial Management

Background:

• Federal policies mandate single Institutional Review Board (IRB) review for multisite studies.
• The objective is to enhance review efficiency while maintaining participant protections.
• The effectiveness and functioning of this single IRB model require empirical evaluation.

Purpose of the Study:

• To investigate the operational aspects and participation rates of single IRBs in research examining their function.
• To identify barriers to participation in studies evaluating single IRB performance.
• To inform policy development and refinement for single IRB implementation.

Main Methods:

• Recruitment of academic, government, and commercial single IRBs (N=49) for observational and/or interview-based study.
• Data collection through observation of protocol review meetings and interviews with IRB members, chairs, and administrators.
• Analysis of participation rates across different types of single IRBs.

Main Results:

• Overall participation rate was 40.8% (20/49).
• Academic (81.8%) and government (50%) single IRBs showed higher participation than commercial single IRBs (23.3%).
• Major commercial single IRBs declined participation, limiting comprehensive evaluation.

Conclusions:

• Encouraging participation from all types of single IRBs is crucial for robust evaluation.
• Low participation, particularly from commercial entities, impedes understanding and refinement of single IRB policies.
• Future research and policy efforts should address barriers to single IRB engagement in performance studies.