Exception from Informed Consent and Waiver of Informed Consent for Comparative Effectiveness Trials in Emergency Care Research

For many of the decisions made in the clinical care setting, clinicians lack evidence to inform which treatment would result in the best patient outcomes. This problem is particularly common in emergency care, a field in which the condition of the patient and the urgent nature of the treatment often preclude research conducted using prospective informed consent. Large-scale comparative effectiveness clinical trials could address the evidence gaps in clinical medicine and improve patient outcomes but are hindered by the lack of a clear regulatory framework in the United States for low-to-minimal risk trials comparing commonly used treatments. In this paper, we summarize a presentation and discussion that took place at a workshop held by the National Institutes of Health that focused on the issue of informed consent and the appropriate regulatory pathway for comparative effectiveness trials conducted in the emergency care setting. A key insight of this workshop is that generating the comparative effectiveness data needed to improve clinical care will require revising ethical and regulatory oversight practices and related guidance to support the conduct of this socially valuable research.