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Flash Learn: Software as a Medical Device

Software, apps, and AI tools are increasingly embedded in research—but when do they cross the line into regulated medical devices? This session provides a practical, IRB-focused overview of Software as a Medical Device (SaMD), helping attendees spot key triggers for FDA oversight and avoid common missteps. Walk away with simple heuristics to support consistent, defensible determinations—without needing to be an FDA expert. CIP®: 0.5 continuing education credit hours

Roundtable Series: Compliance Paradox: Navigating the Intersection of Rules, Ethics, and Participant

Free for members as an exclusive benefit! Based on the new novel by Molly Klote, MD, Compliance Paradox , this four-part discussion series invites Human Research Protection Program (HRPP) professionals, IRB members, researchers, and ethicists to step out of their checklists and into the gray areas of modern biomedical and social-behavioral research. Using key plot points from the novel (including the journey of independent auditor Dr. Elena Richter), we will examine the high-stakes intersection of automated clinical systems, predictive compliance software, and the real human participants caught in the middle. This series will also explore the structural gaps between "procedural compliance" and "substantive participant protection." Join us for a deep dive into the real-world ethical, technological, and regulatory challenges that define the boundaries of modern human research. While reading the novel Compliance Paradox is highly recommended to appreciate the narrative case studies, pre-reading is not required. Each session will provide self-contained summaries of the relevant chapters to anchor our practical, real-world regulatory discussions. For attendees who have a copy of the novel, suggested pre-reading chapters have been included with each session description. CIP®: 4.0 continuing education credit hours