The ethics of research without consent in emergency situations.

In 1996, the federal government published regulations that allow investigators to obtain a waiver of informed consent for emergency research when certain very specific criteria are met. The participants must be unable to give consent as a result of their medical condition, and the intervention involved in the research must be administered before consent from the participants' legally authorized representative is feasible. These regulations require that a number of special protections be provided whenever such a waiver is obtained. Before the study is performed, there must be "community consultation" and "public disclosure." The regulations leave the specific form and extent of these activities to the discretion of the Institutional Review Board granting the waiver of informed consent and the investigator conducting the study. The author reviews the development of these regulations, often referred to as "The Final Rule," the ethical basis for the waiver, and the specific provisions of the federal regulations that govern research without consent in emergency situations. Reactions of proponents, critics and the lay public are discussed.