Exception from Informed Consent in Emergency Care Research: Reports from a Workshop Addressing “Edge Cases”

The ethical challenges of enrolling critically ill patients into emergency care clinical trials without their consent remain, despite a 30-year regulatory framework for conducting research in the emergency setting. In this series introduction, we outline some suggestions to improve studies conducted under the regulatory framework involving an exception from informed consent for emergency care research. These suggestions were made at a recent workshop sponsored by the National of Institutes of Health.