Is it possible to waive the informed consent requirement when conducting research in an emergency setting?
In 1996, the HHS Secretary announced, under 45 CFR 46.101(i), a waiver of the applicability of the regulatory requirement for obtaining and documenting informed consent for a strictly limited class of research, that is, research 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. This waiver applies to research involving adults or children, but does not apply to research involving pregnant women, human fetuses, neonates of uncertain viability, and nonviable neonates, or prisoners. For more detailed information on the Emergency Research Consent Waiver, see OHRP’s guidance at: http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc97-01.htm. It should be noted that FDA also has a comparable provision for a waiver of informed consent for emergency research at 21 CFR 50.24.
