The relying institution relies on the sIRB for IRB review and approval of the protocol but maintains responsibility for all other institutional requirements, which must be completed and then communicated to the reviewing IRB. The specific institutional responsibilities vary by study based on the nature of the research being conducted. These institutional responsibilities can include:

• review and approval of local non-IRB institutional committees—often called ancillary reviews—such as, radiation safety, pharmacy, nursing, biosafety, data security;
• assessment of competency of investigator and staff to conduct the research and review and management of any investigator or institutional conflicts of interest;
• assessment of adequacy of local resources for conducting the research;
• identification of local context issues that may affect the conduct of the research that need to be communicated to the reviewing IRB, such as local standards of care, local laws, and characteristics of the local population; and
• institutional policies, such as the processes for handling noncompliance and assessments of conflict of interest.

In most institutions, the local IRB office or Human Research Protection Program (HRPP) office routinely coordinates and/or documents the myriad institutional reviews. The reviews are usually triggered by submission of a protocol to the local IRB office. In most situations, when an institution cedes IRB review to an external IRB, an application still must be submitted to the local IRB office or HRPP office to initiate and monitor the necessary reviews and sign-offs via a required “local context review.” This means that the site investigator must work with both the sIRB and their own local IRB office or HRPP office.

While the local site review is conducted by the IRB office or HRPP office, this is not a review by an IRB committee and is not designed to assess whether the study meets the criteria for IRB approval. The formal IRB review remains the responsibility of the sIRB.