What Is An sIRB And Why Does My Study Need One?

By Frank Conte, Vice President, Strategic Partnerships

For many years, research sites have primarily depended on institutional review boards (IRBs) administered by the local institutions conducting their research. Independent IRBs have also been an alternative for research sites that don't have their own local IRBs or wish to reduce internal administrative burdens, potentially expediting the initiation of research projects.

Recently, there has been a shift in federal requirements, particularly for multisite clinical trials receiving U.S. government support, mandating the use of a single Institutional Review Board (sIRB) for oversight at all participating sites. This change eliminates the complexity of multiple local IRBs reviewing a single trial and streamlines the process by directing all sites to a single sIRB responsible for ensuring participant protection throughout the entire study.

Furthermore, the FDA has introduced a draft rule indicating its intention to require sIRB review for all studies within its purview, encompassing clinical trials involving experimental products such as drugs and medical devices. Although there is no specific timeline for the implementation of this new rule, numerous institutions are actively strategizing how to navigate these evolving requirements in their research management practices.

Consider the policies, processes, and benefits outlined in this article when deciding whether to establish a collaborative and compliant working relationship with an sIRB.