Prospective informed consent is a cornerstone of ethical human subjects research, grounded in the principle of respect for persons. Under the Common Rule, waivers or alterations of consent may be approved only when specific criteria are met—yet the requirement that the research could not practicably be carried out without the waiver remains one of the most challenging and inconsistently applied. This session examines how investigators and IRBs interpret and operationalize “impracticability” in waiver of consent determinations. Speakers will review the regulatory framework and relevant guidance, explore areas of persistent ambiguity, and analyze real-world scenarios where feasibility, bias, cost, and scientific validity intersect. The session will also introduce practical tools—including structured approaches and review checklists—to support more rigorous, transparent, and consistent determinations. Attendees will leave better equipped to evaluate and justify waiver requests in a way that aligns with regulatory expectations while minimizing ethical and institutional risk.
CIP®: 1.5 continuing education credit hours