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Workshop: Risk Assessment Reimagined: Evaluating Non-Traditional Risks in Digital and Behavioral Res

Traditional IRB risk assessment focuses on immediate harms to individual participants, but digital and behavioral research could now introduce diffuse, downstream, and group-level risks like algorithmic bias and stigmatization. Although 45 CFR 46.111(a)(2) tells us that risks involving the "possible long-range effects of applying knowledge gained in the research" are not in the IRB's purview for approval criteria, IRB professionals still encounter ethical questions about emerging forms of risk in data-intensive environments. In a world where content is posted with little expectation of privacy and companies consume large-scale personal data for business use, let's discuss ways that IRBs can think ethically about the new frontier of risk while remaining grounded in regulatory authority. CIP®: 1.5 continuing education credit hours

Workshop: When PAM Findings Trigger Action (and When They Shouldn't)

Post-Approval Monitoring (PAM) programs generate a steady stream of observations—but not every finding warrants corrective action, reporting, or escalation. Yet many IACUC programs struggle with inconsistent responses, overcorrection, or uncertainty about when a finding rises to the level of noncompliance or reportability. This 90-minute interactive workshop brings together real-world PAM scenarios, QA/QI strategies, and evolving reporting expectations to help attendees calibrate their responses. Drawing on institutional PAM models, procedural observation practices, and recent discussions around reporting gray areas, speakers will walk through how to distinguish between minor deviations, systemic issues, and reportable events. Attendees will leave with practical frameworks to support consistent, risk-based decision-making—strengthening both compliance and program credibility without creating unnecessary burden. CPIA®: 1.5 continuing education credit hours