When UAB is Prime and Arranging Single IRB Review
Information about Review by Independent IRBs
Initial Review includes both the initial review by the independent IRB as the single IRB, as well as the initial review performed by the Relying HRPPs. Each stakeholder has responsibilities during this stage.
The PI and Lead Study Team are responsible for communicating with the independent IRB and making the initial submission of the overall protocol to the independent IRB. This will follow the same process for when UAB is Site - Rely on External IRB​ and submits the Institution Review Form for Relying on External IRBs to the UAB Office of the IRB via IRAP.
The Lead Study Team should work with the independent IRB to ensure communication occurs between the independent IRB and the Participating Study Teams.
During the initial review stage, the Participating Study Teams are responsible for completing all of the non-IRB requirements at their local institution (Relying HRPP requirements) and getting that information to the independent IRB as required by that independent IRB.
The independent IRB will communicate with the Lead Study Team and Participating Study Teams about IRB-related decisions and determinations that are part of the initial review and ongoing reviews.
Details about additional requirements of the independent IRB will be communicated by that independent IRB.