Empirical Research Ethics Track
2019 AER Conference
B03 - Why Informed Consent Doesn't Work and Why the Revised Common Rule Won't Fix It
Quincy J. Byrdsong, EdD, CIP, CCRP
Associate Vice President for Research Administration, WellStar Health System
Stephanie S. Cargill, PhD
Associate Professor, Center for Health Care Ethics, Saint Louis University
Speaker(s)
The revised Common Rule includes revisions to the "content, organization, and presentation of information included in the consent form and process." While revisions to the Common Rule have yet to be tested, previous interventions on the means of transmitting information to achieve informed consent have seen limited success, despite the amount of time and energy devoted to developing and implementing them. A central reason these interventions fail may be they fundamentally misunderstand how potential participants communicate and come to decisions regarding research. This session will review the barriers to participants understanding the informed consent information may not be based solely in the way information is transmitted to participants, which is the current focus of these interventions. Rather, following the health communications field in thinking about communication as a more complex phenomenon that is bidirectional, impacted by physical, psychological, social, and relational contexts, as well as the social norms that govern the broader context of which consent for research, is important. Until those working on informed consent recognize how these factors can serve as barriers and facilitators to communication, even the most radical improvements to the "content, organization, and presentation of information" will have minimal impact. During this session, speakers and attendees will:
Learning Objectives:
- Learn about empirical interventions and their (limited) results around improving informed consent
- Explore the health communication literature relevant to how the human subjects research field approaches informed consent
- Engage new avenues of intervention based on the insights of health communication