Reviewing IRB Responsibilities

Reviewing IRB Responsibilities

The IRB chosen to provide review – the reviewing IRB – has to fulfill the same responsibilities as any other IRB. In fact, those same responsibilities can become more difficult to carry out since the information that could previously be gathered from one site must now be gathered from multiple sites. The reviewing IRB has to make the same determinations without the benefit of knowing the investigators, how they conduct research, or the resources available to them.

To provide appropriate IRB review for all sites, the reviewing IRB examines the protocol’s basic information (e.g. procedures, risks, benefits, data safety monitoring, template consent language) to determine whether the protocol meets the federally mandated criteria for approval. Then the reviewing IRB considers each site individually and how each site will implement the protocol locally, collecting information about investigator qualifications and local context information, and incorporating site-specific language into template consent and authorization documents.

The reviewing IRB also has to ensure that any institutional requirements applied by the participating sites have been completed (e.g. human subjects training, conflict of interest disclosure, scientific review, radiation safety review). These activities are often tracked on a local level using site-specific electronic systems that are not available to the reviewing IRB. Therefore, that information also has to be collected and considered for all sites.

All of these steps facilitate the initial review. Ongoing review, including amendments, renewal, and review of reportable events, requires additional information specific to the submission and the specific sites affected.

All in all, serving as the reviewing IRB can be complicated and requires a significant amount of coordination by IRB staff to:

  • ensure investigator compliance with the protocol;
  • oversee the sIRB's determinations;
  • ensure applicable federal and state regulations; and
  • ensure TTUHSC El Paso policy.


At TTUHSC El Paso, we are still in the process of enhancing our electronic IRB system to help coordinate IRB review of multiple sites. In the meantime, additional site-specific forms are often required.

The TTUHSC El Paso IRB may not consider sIRB review when:

  • The project involves prisoners or vulnerable populations that require special considerations;
  • The proposed IRB of record does not have sufficient knowledge of local context or a robust human subject program (as required by federal guidelines) to assume IRB oversight for sites that fall under TTUHSC El Paso HRPP purview;
  • A TTUHSC El Paso study team member has a conflict of interest that requires a management plan, and the management plan prohibits or limits activities that the individual can engage in related to human subjects research; or
  • A TTUHSC El Paso study team member has a history of non-compliance with IRB policies or processes.