Ethics of Research without Informed Consent

US federal regulations commonly referred to as the Final Rule permit certain emergency and critical care research involving human subjects to take place without obtaining prospective informed consent. Since its passage in 1996, there remains significant controversy over the proper application of the Final Rule in clinical trials seeking an exception from informed consent. This chapter provides a brief review of the history and provisions of the Final Rule, followed by a discussion of the ethical considerations of conducting human subjects research without obtaining prospective informed consent. Remaining ethical challenges to the Final Rule are examined, and recommendations for its future implementation are proposed.