Informed consent is a cornerstone of ethical research, but without accounting for health literacy, it often fails to ensure true participant understanding. This session will explore how research professionals can bridge the gap between regulatory compliance and meaningful comprehension, particularly in sensitive fields like reproductive health. Drawing from real-world experience in Phase III trials, biorepository studies, and community health research, I will share practical strategies for improving the consent process using plain language, teach-back methods, and visual aids. We’ll also examine relevant ICH-GCP guidelines, including the requirement that consent information be presented “in a language understandable to the subject,” and discuss how these principles apply in daily research practice. Attendees will leave with actionable tools to support participant-centered communication and to elevate the informed consent process beyond a signature to a personal, nuanced, and regulatory-compliant conversation that leaves patients feeling empowered in their decision.

CEU: 1.00 ACRP

Speaker:

• Gianna Gemignani, BS, ACRP-CP, Clinical Research Project Coordinator, University of Wisconsin-Madison School of Medicine and Public Health (Department of OB/GYN)