A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

Single IRB Review is an arrangement in which one institution's IRB provides review, approval and oversight for the Human Research activities of multiple institutions. This is intended to streamline ...

When is IRB Approval Required? If your project involves "research" and "human subjects" as defined by 45 CFR 46, you must submit an application to the Case Western Reserve University Institutional ...

UAB may be a participating site in a multi-site research study and rely on an external IRB. The external IRB may include an institutional IRB (e.g., Vanderbilt) or an independent IRB (e.g. WIRB or ...

The University IRB uses consultants to supplement IRB review when a specific project requires expertise beyond the scope of IRB membership. For example, a project/package may require: scientific or ...

Occasionally, protocols require investigators or other institutions to rely on one another to perform an IRB review. Please see this guidance if wanting more information about Individual Investigator ...

The basis for the single IRB model is to allow multiple sites that are conducting the same protocol to use a single IRB for review, instead of using multiple IRBs to review the research at the sites ...