Reviews

Why Should Local IRBs and HRPPs Collaborate with External IRBs? 

Multisite research and clinical trials increasingly rely on a single IRB (sIRB) for review. This increase reflects federal mandates, sponsor expectations, and the operational realities of modern multisite or cooperative research.    For institutions with a local

The Executive Order that Brings Private Bioresearch Under Federal Oversight

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.

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