When submitting an IRB application, choosing the right application type helps to ensure a more efficient review process.

The protocol-based application (PBA) is appropriate in the following scenarios: studies involving clinical interventions; more than minimal risk studies; creation of registries and repositories; and clinical trials. See Protocol-Based Application (PBA) guidance for more detailed information.

The non-protocol-based application (nPBA) is appropriate for: exempt studies; most education and social/behavioral science studies; studies that qualify for expedited review as outlined in HRP-313; and health care record review studies. See Non-Protocol-Based Application guidance for more information. When submitting an nPBA, it is not necessary to also include a standalone protocol document.

For studies in which machine learning and/or artificial intelligence (AI) is involved, one in which the machine learning algorithm and/or AI is still in the development stage is likely to be appropriate for an nPBA application. Once you have progressed to later stages of development, such as deploying the algorithm/AI in a live clinical environment, a standalone protocol document submitted with a PBA may be required.

As always, if you are unsure about which application type is most appropriate for your study, please contact the IRB office.