C03 - What's in a Waiver? Making Room for Flexibility in the Consent Process
Thursday, November 6, 2025
3:30 PM - 4:30 PM ET
Informed consent is a cornerstone of ethical research, yet the process of ensuring that participants make truly informed decisions extends beyond the use of a traditional paper form. This session will explore approaches to obtaining consent in ways that are meaningful, accessible, and tailored to participants’ needs. Through discussion and real-world examples, speakers and attendees will examine strategies for investigators and IRBs to enhance comprehension, promote engagement, and adopt flexible, participant-centered consent practices.
Learning Objectives:
Review the federally required elements of informed consent and the criteria for granting waivers
Differentiate between “impractical” and “impracticable” considerations in the context of research design and implementation
Analyze case studies to explore how IRBs apply consent waivers in various research scenarios, such as studies involving deception or opt-out consent