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On 2 October 1996 the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) each published a final rule allowing emergency research to proceed without the consent of its participants in a strictly limited circumstance. This waiver of informed consent applies to “research activities that may be carried out in human subjects who are in need of emergency therapy and for whom, because of the subjects’ medical condition and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained.”