Waived Consent for Emergency Research

Abstract

The voluntary consent of the human subject is absolutely essential.Contrary to the first principle of the Nuremberg Code, the voluntary consent of the human subject is neither necessary nor sufficient for ethically and legally responsible research in the United States. That it is not sufficient has been well argued by Robert Burt and others. We would not say that the central problem of the Nazi experiments was their failure to obtain informed consent. Nor would the presentation of signed and witnessed consent forms change anyone's view on the moral justification for the experiments. For related reasons, institutional review boards (IRBs) sometimes reject or defer protocols for paternalistic or various other reasons, arguing that clinicians should not allow patients to consent to be subjects in a study.