Beginner’s Guide to Single IRB Mandates
As clinical trial efficiencies grow, understanding single IRB mandates becomes crucial for sites and sponsors navigating ethical review processes.
As clinical trial efficiencies grow, understanding single IRB mandates becomes crucial for sites and sponsors navigating ethical review processes.
In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated sIRB for multisite research.
Central and local IRBs share the same research oversight goals, but NIH’s single IRB mandate challenges local IRBs to adapt their broader responsibilities.
Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.