Unconsented: Research Conducted with Exceptions to Informed Consent Waivers

Emergency medical situations need evidence-based interventions, but clinical trials in these contexts are challenging in part because patients cannot provide informed consent. Should we not conduct traditional trials in these circumstances? Is community-level consent an appropriate substitute? How can we handle variations in trust that different communities have in the medical system? This session will consider the ethical and legal challenges of emergency clinical research, policies related to waiving informed consent, and lessons learned from studies that have received waivers.

Discussants
(1) Neal W. Dickert, MD, PhD
(2) Carrie Sims, MD, PhD
Moderator
(3) William B. Feldman, MD, DPhil