Panel III: Exception from Informed Consent (EFIC) for Research at 25

Thursday, November 18, 2021

11:30 AM – 12:45 PM ET

Location: Livestreamed

The EFIC for Research in emergency settings was passed 25 years ago. In this time, significant experience has been accumulated, and important studies have been conducted. However, there remain challenges related to the ethical and regulatory aspects of this significant category of research. These challenges can be significant for investigators and for IRBs. There is lingering uncertainty about the most effective approaches to community consultation and public disclosure as heterogenous practices and expectations have emerged. Important questions have arisen about the scope of EFIC regulations, specifically, about when consent is truly impracticable, what to do in situations where capacity is marginal or variable, and about how to approach studies evaluating standard of care interventions. Finally, questions have been raised regarding minority inclusion in and perspectives on EFIC research. This panel brings together experts to address these important issues, reflecting on the past 25 years of EFIC.

Moderator(s)

Neal W. Dickert, MD, PhD

Emory University School of Medicine, Division of Cardiology
Emory University School of Medicine

Speaker(s)

Michelle Biros, MD, MS

University of Minnesota School of Medicine
Minneapolis, MN
Adrianne Haggins, MD, MS

University of Michigan Medical School
University of Michigan
Michael J. Linke, PhD, CIP

University of Cincinnati College of Medicine
University of Cincinnati
Robert Silbergleit, MD

University of Michigan
University of Michigan Medical School
Ann Arbor, MI