Single IRB Review: Tips For Sponsors And CROs Working With Institutional Sites

In 2022, the FDA proposed a rule mandating single institutional review board (sIRB) oversight for most multisite clinical trials under its regulation, signaling a shift expected to reshape research practices across stakeholders. While institutions funded by NIH and those governed by the Common Rule have adapted to sIRB mandates, the FDA's regulation could introduce significant operational challenges for sites that primarily conduct industry-sponsored research. Sponsors and contract research organizations (CROs) will need to adapt their processes and policies to align with the FDA’s requirements, making early preparation essential. By collaborating with sites now, sponsors and CROs can address potential impacts, paving the way for smoother implementation if the rule is finalized.

This eBook provides a toolkit to:

• Understand the institutional IRB’s role when sIRB review is utilized
• Assess and update policies to comply with sIRB requirements
• Leverage best practices to optimize sIRB efficiencies