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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.
Planned emergency research applications require consultation with the Vice Dean for Clinical Investigation prior to IRB review. Legal counsel and OHSR compliance staff will assist the IRB in making the required determinations to comply with FDA and DHHS regulations. Guidance on regulatory requirements will be provided to the research team and IRBs on a case-by-case basis.