As noted previously, IRB approval can be obtained from an institution’s internal IRB or from an external IRB, such as an independent IRB or an IRB at another institution. The IRB completing the review is the “reviewing IRB,” and the institutions that rely on the external IRB are the “relying institutions.”

The requirements for the reviewing IRB and the relying institution are the same whether the project is using an sIRB for multisite research or an external IRB for a single-site study.

The main goal of using an sIRB for multisite research is to streamline the review process by eliminating duplicative and potentially conflicting reviews at the clinical trial sites. There has been a dramatic increase in the use of the sIRB review model in response to the 2016 NIH policy requiring sIRB review for NIH-funded multisite research (NIH 2016) and the requirement for sIRB review of cooperative research set forth in the revised Common Rule (45 CFR §46).

When a study uses  sIRB review, the investigators must identify an IRB to serve as the reviewing IRB (or the “IRB of record") for the study. The proposed IRB must agree to serve in this role, and of note, an IRB can refuse to serve as an sIRB.

Participating sites must agree to use the designated sIRB and complete a formal institutional reliance agreement which cedes IRB review to the reviewing IRB. As noted below, the relying institutions retain several responsibilities beyond IRB approval.

The relying institutions rely on the sIRB for review and approval of the protocol but maintain responsibility for all other institutional requirements, which must be completed and then communicated to the reviewing IRB. This collaboration allows the sIRB to include such site-specific information in the review of the protocol. 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, and data security
• Assessment of competency of investigators 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
• Institutional policies, such as 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 institutional signoffs via a required “local context review.” This means that the site investigator must work with both the sIRB and their own local IRB or HRPP office and be certain that the sIRB receives documentation of the institution-specific information.

While local site review is conducted by the local IRB or HRPP office, this review does not constitute 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.

The reviewing IRB is responsible for all IRB actions during the life of the protocol, including:

• Continuing review
• Review of all protocol amendments
• Review of any unanticipated events
• Handling participant questions and complaints
• Consideration and required review of deviations and noncompliance
• Closure of the protocol upon completion of the study

The relying institution remains responsible for ongoing local context review throughout the life of the study. This may include:

• Review of protocol amendments if a local context issue is triggered, such as:
  • The amendment requires additional review by an institutional ancillary committee
  • The amendment involves addition of new research staff that require review of credentials, training, or conflicts of interest
  • The amendment has implications for local state laws or institutional policies and adherence with regulatory or policy requirements must be addressed
• Coordination with the reviewing IRB for addressing incidents of noncompliance if local institutional research personnel are involved in the possible noncompliance or if the noncompliance results in changes to or termination of the research
• Coordinating with the reviewing IRB to handle local participant questions and/or complaint
• Maintaining records of institutional research activity (meaning that relying institutions must be aware when the research is completed or otherwise terminated)