F04 - Redrawing the Line: Informed Consent and Therapeutic Misconception in Decentralized and Patient-Centered Research

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As "patient-centered research" and "research as a treatment option" gain prominence, the boundary between clinical care and clinical investigation is becoming increasingly blurred—particularly in the context of decentralized clinical trials. This evolving landscape raises critical ethical and regulatory questions: Should we be concerned about the erosion of this distinction? How does it contribute to therapeutic misconception, where participants may conflate research with individualized care? And what role should IRBs play in recognizing and addressing these challenges? This session will explore the implications of this shift and examine whether—and how—IRBs should work to reestablish or rethink the boundary between research and care.