Single IRB (sIRB) refers to a regulatory review model in which one Institutional Review Board serves as the IRB of record for all participating sites in a multi-site research study.
The sIRB model is designed to streamline ethical review and oversight across multi-site clinical research by eliminating duplicative IRB reviews at each participating institution. Under this framework, the reviewing IRB assumes primary responsibility for evaluating the study protocol, informed consent materials, and participant protections, while relying institutions maintain responsibility for local oversight requirements, investigator qualifications, and institutional compliance obligations.
Implementation of an sIRB model requires coordination among sponsors, CROs, research sites, and institutional stakeholders to establish reliance agreements, define responsibilities, and manage communication workflows. Challenges may include varying institutional policies, local context considerations, and delays in documentation exchange or reliance onboarding. When supported by standardized processes, clear governance structures, and effective collaboration, the sIRB approach can improve study startup efficiency, reduce administrative burden, and promote more consistent oversight across participating research sites.