April 2008 The Organization allows the IRBs to review research activities that plan to enroll human subjects in research that will be conducted in an emergency situation in which consent cannot be obtained from subjects due to their medical condition and cannot be obtained by a subject’s legally authorized representative. Planned emergency research applications may be either research subject to FDA regulations or research that is not subject to FDA regulations. Research that is subject to FDA regulations and will be carried out under an FDA IND application or an FDA IDE, will be reviewed by the IRB in accord with FDA regulations 21 CFR 50.24. Research that is not subject to FDA regulations will be reviewed under the DHHS Emergency Research Consent Waiver effective November 1, 1996. As of March 2008, the JHM IRBs have not reviewed and approved any application for planned emergency research that includes a waiver of consent. Planned emergency research applications require consultation with OHSR to make a determination on the applicability of FDA and DHHS regulations. Guidance on regulatory requirement will be provided to the research team and IRBs on a case-by-case basis.
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