When must an institution establish its own IRB?

An institution is not mandated to establish its own Institutional Review Board (IRB) under all circumstances. This flexibility allows institutions to decide based on their specific research activities and needs. Many institutions choose to use an external IRB or rely on a central IRB, especially if they do not conduct a significant amount of research that requires ongoing IRB review.

In situations where institutions may not be involved in high-risk or federally funded research, the establishment of an IRB may not be necessary. This decision often depends on the volume and nature of research conducted at the institution. Institutions conducting minimal research or participating in research that is exempt from IRB review may find it more practical to collaborate with established IRBs rather than create their own, thus reflecting the variability in research contexts and requirements.

It's essential for institutions to evaluate their specific research scope and compliance needs before deciding to set up an IRB, demonstrating a tailored approach to human research protections.