D11 - Conducting an Effective IRB Review of Artificial Intelligence (AI) Human Subjects Research (HSR) (The Non-Clinical Edition)

Social Behavioral and Education Research (SBER) involving AI/Machine Learning (ML) applications has received less attention than its counterpart, clinically based research involving AI/ML. This may be because the Common Rule currently does not have an established regulatory framework for HSR involving AI/ML, while clinical studies have general regulatory guidance that does cover this technology broadly. As a result, and because SBER studies involving AI/ML can be nuanced, conducting an effective IRB review and making decisions in SBER studies that involve AI/ML is often more challenging. This session will walk the audience through the current regulatory frameworks under the Common Rule using a targeted approach: Relying on the AI HSR checklist to review non-clinical AI HSR; using case studies to help work your way through several typical non-clinical AI applications; making AI HSR and exempt determinations; and discussing various consent options in non-clinical AI HSR, such as group consent. Click to read Conducting an Effective IRB Review of Artificial Intelligence Human Subjects Research (AI HSR) (The Non-Clinical Edition).