Acting without asking: An ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research

This article summarizes the current requirements for a waiver of informed c onsent for emergency research and analyzes ethical issues that are involved . Researchers who intend to apply for a waiver of informed consent for emer gency research must understand that they are asking for the major protector of human subjects, the informed consent process, to be removed. In its abs ence, other protections are required. These include communication with the community, family members, and others close to the patient. It is unlikely that even these additional protections can equal that afforded by an adequa te consent process. With this understanding, investigators' actions must be in accordance with the highest ethical standards. It is therefore necessar y for investigators to know the ethical implications of conducting controll ed research without the subjects' consent.