Waiver of Informed Consent Requirements in Certain Emergency Research

The Department of Health and Human Services (HHS) is announcing the waiver of the applicability of the title 45 CFR part 46 (protection of human subjects) requirement for obtaining and documenting informed consent, for a strictly limited class of research involving activities which 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. However, because of special regulatory limitations relating to research involving prisoners (subpart C of 45 CFR part 46) and research involving fetuses, pregnant women, and human in vitro fertilization (subpart B of 45 CFR part 46), this waiver is inapplicable to these categories of research.